APRIL/MAY 2017 Vol. 10 No. 2 VEINTHERAPYNEWS.COM
Velano Vascular raises $17 million 8 Cardiologist wins 100K BSN-JOBST AVF grant 8 FDA warns of MACE event risk with Absorb BVS 12 Physician blasts Novitas LCD 27 ACP PRO Venous Registry: 19,000 patients plus 30
An ACP recognized resource for news and information for and about the phlebology community
ACP mobilizes to oppose Novitas draft LCD By Keith A. Darby, CAE, CMA, CFE
advocating for the society in matters relating to Medicare, insurance companies and thirdparty payer issues. At each opportunity, the ACP has expressed its interest in working with these organizations by providing content experts to help the carriers develop policies for the treatment of the disease process that are consistent with the scientific literature, and is committed to generating greater clinical data and evidence through the ACP PRO Venous Registry and through collaboration with other registries. More than ever, in an environment of limited public resources and concerns about overutilization, we must rely on the available peer-reviewed evidence to demonstrate medical necessity and best practices in the treatment of superficial and deep venous disease.
The landscape of insurance is changing, with a current focus on cost cutting strategies that disregard scientific evidence and a trend towards greater consistency in policies that are administered by some of the Medicare Administrative Contractors (MACs). As a result, a compelling need exists for the advocacy efforts of the American College of Phlebology (ACP) to oppose all such egregious policies, as they may be mirrored in whole or in part by other MACs. A direct stance must at times be taken in order to advocate for access to evidence based care for our patients. Recently, the ACP has started to take a more hands-on approach towards
continued on page 16
UNETHICAL VEIN CARE
Is vein care following the path of hemorrhoids? By Jeffrey H. Miller, MD “The first step is admitting you have a problem.” And when it comes to ethical vein care, we have a problem. With the increased number of vein practitioners and
clinics across the country, we must address this dilemma immediately. The good news is that the topic is getting publicized at national meetings as well as in print. The bad news is that if we don’t do anything about it, others will. Our battles
with insurance carriers for coverage of indicated procedures may only get worse.
TEMPTATION OF FRAUD Sadly, “The sins of the few often cause the punishment of the many,” and this applies to
the field of medicine. Sweeping legislation and onerous regulation punishes physicians who would practice ethically without such UNETHICAL VEIN CARE
continued on page 24
Teleflex completes $1B deal The $1 billion acquisition of Vascular Solutions by Teleflex closed Feb. 17 after Vascular Solutions shareholders approved the deal the day before. Teleflex Inc., a global provider of medical technologies for critical care and surgery, and Vascular Solutions, a medical device company that focuses on developing clinical solutions for minimally invasive coronary and peripheral vascular procedures announced on Dec. 2, 2016, a definitive agreement for Teleflex to acquire all of the issued and
outstanding shares of Vascular Solutions common stock for $56 per share, in cash. The combination of products is expected to accelerate the growth of Teleflex’s vascular and interventional businesses by its entry into the coronary and peripheral vascular market, as well as increased cross-portfolio selling opportunities to both Teleflex and Vascular Solutions customer bases. TELEFLEX
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NEWS 1 ACP moves against draft LCD The landscape of insurance is changing, with a current focus on cost cutting strategies that disregard scientific evidence and a trend towards greater consistency in policies that are administered by some of the Medicare Administrative Contractors. The ACP mobilized quickly in opposing a Novitas draft LCD.
1 Vascular Solutions deal closes The $1 billion acquisition of Vascular Solutions by Teleflex closed Feb. 17 after Vascular Solutions shareholders approved the $56 per share deal the day before. Teleflex Inc., a global provider of medical technologies for critical care and surgery, acquired Vascular Solutions, a medical device company that focuses on developing clinical solutions for minimally invasive coronary and peripheral vascular procedures.
THE PRACTICE 21 A website…so what? Everyone knows that a website is essential in keeping your clinic thriving with new business. But there are things you should do to optimize your digital presence and get clients through the door. Author Michelle Huie offers some tips that helped her get her business over the top.
23 Having the RIGHT STUFF Author Carolyn Coffin observes that the injury rate among sonography professionals continue to be higher than other industries. She discusses the right stuff for a worker-friendly environment: scheduling, review of exam protocols, support for work breaks and a mechanism for reporting injury.
SECOND LOOK 1 Unethical Vein Care We continue to hear from readers about horrific examples of unethical medical practice in the treatment of venous disorders. Author Jeff Miller discussed the issues with a couple of physicians in other fields, and found that we are following our own version of “Scoping for Dollars,” a problem that led to the influx of lesser trained endoscopists chasing imaginary hemorrhoids. He compares this to vein patients he is now seeing who were treated by lesser trained interventionalists.
25 Ethical dilemma of being FIRST A specialist recalls the disaster of gall bladder surgery in the 1980s as surgeons rushed to be the FIRST to do minimally invasive gallbladder surgery. No science, no proof. Some patients paid dearly for this race. Fast forward to the turn of the century and again surgeons were rushing to be FIRST to perform laparoscopic colon surgery and to be the FIRST to remove cancers through these new mechanisms. Author Harry Wasvary, MD, details the race to be the FIRST.
VTNREPORT MEDTRONIC’S OUTCOME-BASED TRAINING PROGRAM INTRODUCED IN EMEA Medtronic is launching an outcomes-based training program in Europe, the Middle East and Africa that aims to reach 500,000 healthcare providers over the next five years. It’s part of the push toward “value-based healthcare chairman & CEO Omar Ishrak has championed for years. The new program, Medtronic Impact, goes beyond traditional training on products and procedures. “Medtronic Impact is a significant investment that sets an entirely new standard for professional development in the medical technology industry,” EMEA president Rob ten Hoedt said. “Its new, extensive curriculum will not only equip [healthcare providers] to access training that is relevant to their clinical skills development, but it will also build a wider range of nonclinical capabilities as we move increasingly towards a VBHC environment. “We are going to go from pure technical training to a much more integrated care approach allowing health professionals to think about what has happened before and what is happening after their intervention with the patient,” ten Hoedt said. The program is also collaborating with providers to create specialized training programs focused on outcomes, Medtronic said. Participants so far include Barcelona Campus of Catalonia, Spain; Strasbourg, France’s IRCAD; Sunskill Laboratory at South Africa’s Stellenbosch University; and the Dundee Institute for Healthcare Simulation at the University of Dundee in Scotland. Learning & Innovation Senior Director Mike Roby said collaborations with world-class healthcare institutions will enable Medtronic to radically transform how it designs and delivers training and education. “We firmly believe that the collective efforts of the network we’re cultivating will create more value and positively impact outcomes that matter to patients.” Medtronic Impact also aims to use “newly-developed, online immersive education experiences” with a personalized web portal, virtual classrooms, augmented reality and remote case observation, the company said.
COSMETIC SURGERY THRIVES Demand for cosmetic surgery is showing no sign of abating, with a boom in Asia as the procedures become more affordable and less of a taboo, experts said. The global market grew by 8.3 percent in 2016 to an estimated value of $8.9 billion – the GDP of the Bahamas, according to data released Friday at the IMCAS aesthetic industry conference in Paris. In 2017, people are projected to spend $9.83 billion on face and body upgrades, growing to nearly $12.82 billion in 2020. “There’s a general acceptance that doing, whether it’s surgery or less invasive procedures…to make you feel better, look better, it’s much more accepted,” Nolan Karp, a New York surgeon and board member of the American Society for Aesthetic Plastic Surgery, said. Demand in Asia is exploding, practitioners say, driven by a rapidly growing middle class and a quest for more Caucasian features. Behind the United States and Brazil, South Korea was the third biggest market for aesthetic treatments in 2015, with 1.2 million procedures out of a global total of 21.7 million, according to data from the International Society of Aesthetic Plastic Surgery (ISAPS). While breast augmentation and liposuction are the most popular procedures in America, Brazil, Mexico and most of Europe, demand in South Korea is for eye, nose, cheek and chin re-sculpting.
PATIENT SAFETY, SCIENCE & TECHNOLOGY SUMMIT HONORS MOVEMENT HEROES AT 5TH ANNUAL MEETING Joe Kiani, founder of the Patient Safety Movement, said at the 5th Annual Patient Safety, Science & Technology Summit, that 69,519 lives were saved in 2016, thanks to the efforts of more than 3,526 hospitals committing to patient safety and the 70 healthcare technology companies who have signed an open data pledge. “By January 2016 we announced 24,643 lives were saved, and we made the goal to reach 50,000 lives saved by this year. As of February 2017, we’ve more than doubled that number.” Former Vice President Joe Biden noted the importance of being “unwilling to postpone” the fight to achieve zero preventable deaths by 2020. “We cannot spend billions on sublime new therapies to save lives from cancer, only to lose them tragically as a consequence of predictable mistakes.”
During the Feb. 4 proceedings, there was an exclusive screening of the documentary “Clean Hands,” which tells the story of Professor Didier Pittet’s 20-year campaign to promote hand hygiene as a means of preventing nosocomial infections. Those infections are estimated to kill 16 million people worldwide each year. Professor Pittet is an ambassador to the World Health Organization and a speaker at this year’s Summit. Also taking place Feb. 4 was a panel discussion on the first of three new Actionable Patient Safety Solutions (APSS) introduced at this year’s event, regarding venous thromboembolism (VTE). The Centers for Disease Control (CDC) estimates that as many as 70 percent of hospitalacquired cases of VTE are preventable, making the need for hospitals to improve awareness and develop new processes acute. The panel, moderated by Mike Durkin, the British National Health Service’s Director of Patient Safety, discussed the challenges surrounding VTE prevention. Honored at the first day of the Summit were those who have made the greatest contributions in 2016 toward achieving the PSMF’s goal of zero preventable patient deaths by 2020. The 2016 Humanitarian Awards recognized the lifesaving achievements of the following leaders in patient safety: Patrick H. Conway, MD, MSc; Dave Mayer, MD; Annamarie Saarinen; and Anne de-Wahl Granelli, PhD, MBA. READ MORE: patientsafetymovement.org/
HOLOGIC GETS INTO MEDICAL AESTHETICS WITH $1.65B ACQUISITION OF CYNOSURE Diagnostics company Hologic has gotten into medical aesthetics with an acquisition of Cynosure worth approximately $1.65 billion. The all-cash transaction is expected to close in March or April. It will be funded with cash on hand, which includes proceeds from the $1.85 billion divestiture of its blood-screening business to longtime partner Grifols. The deal will serve as Hologic’s entry into the medical aesthetics space – which includes noninvasive body-contouring devices – while also expanding Cynosure’s market reach, the companies said in a statement. “We had identified medical aesthetics as an attractive and complementary growth opportunity through our strategic planning process, and are pleased to have agreed to acquire Cynosure, the best-in-class company in the space,” Hologic CEO Steve MacMillan stated in the release. Hologic’s announcement comes a day after competitor Allergan announced it would pick up Zeltiq, which markets the fat-freezing CoolSculpting system, to boost its aesthetics offerings. In addition to body-contouring systems, Cynosure CEO Michael Davin said Cynosure markets devices for hair removal, tattoo removal and the treatment of surgical and acne scars. The company posted $433.5 million in revenues for 2016, a 28 percent leap from its sales haul the previous year. “Strategically, this deal enables Cynosure to further capitalize on growth opportunities in the core and non-core aesthetic market, rapidly strengthens our position in women’s health – where Hologic has a leading commercial presence – and accelerates our R&D initiatives.”
TRUMP ADMINISTRATION CHOOSES BRIAN NEALE TO LEAD MEDICAID, CHIP The Trump administration has chosen Brian Neale, who helped create Indiana’s conservative version of Medicaid expansion, to lead the Center for Medicaid and CHIP Services. Neale, who is currently executive director of the United States Congress Joint Economic Committee, previously served as the healthcare policy director under Mike Pence when he was the governor of Indiana. In that role, Neale worked with Seema Verma – who is awaiting confirmation on her nomination to head the Centers for Medicare & Medicaid Services – to design the state’s Medicaid demonstration project known as Healthy Indiana (HIP) 2.0. An alternative to Medicaid expansion approved by the Obama administration, HIP 2.0 requires enrollees to contribute a small amount of health insurance premiums each month to a special health account, and has a complex set of rules to encourage beneficiaries to save money and use preventive care. Also in March, the Senate approved the nomination of Verma to head the Centers for Medicare & Medicaid Services. VT N
APRIL/MAY < VEIN THERAPY NEWS
Not actual patients.
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Offer a comprehensive GSV system solution for above and below the knee. Varithena® (polidocanol injectable foam) 1% reaches veins that others can’t—treating a wide range of sizes and any vein shape including tortuous and varicosities above and below the knee. Varithena’s UDSS formulation—uniform density, size and stability—results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying venous incompetence, improves vein appearance and shows significant PRO improvements with an established safety profile. Now, with a 30-day post-activation shelf life, treating patients with Varithena® is easier than ever.
Now approved with a 30-day post-activation shelf life.
For more information on treatment, visit Varithena.com INDICATIONS Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. IMPORTANT SAFETY INFORMATION The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®
© 2016 Biocompatibles, Inc., a BTG International group company All rights reserved NA-VAR-2016-0786(1) 08/16 Varithena is a registered trademark and Varithena Solutions Center is a trademark of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd btg-im.com
Varithena® (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 Brief Summary of Prescribing Information. For complete Prescribing Information, consult official package insert. INDICATIONS AND USAGE Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
In Varithena®-treated patients, 80% of pain events in the treated extremity resolved within 1 week.
DOSAGE AND ADMINISTRATION Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities.
Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.
Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena®. CONTRAINDICATIONS The use of Varithena® is contraindicated in patients with: • known allergy to polidocanol [see Warnings and Precautions] • acute thromboembolic disease WARNINGS AND PRECAUTIONS Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Venous Thrombosis Varithena® can cause venous thrombosis [see Adverse Reactions]. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena® at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena® in placebo-controlled clinical trials. Adverse reactions occurring in 3% more patients receiving Varithena® 1% than receiving placebo are shown in Table 1. Table 1: Treatment-emergent adverse reactions (3% more on Varithena® 1% than on placebo) through Week 8 (n=588) Adverse Reaction Pain in extremity Infusion site thrombosis b Contusion/injection site hematoma Limb discomfort Tenderness/injection site pain Venous thrombosis limbc Thrombophlebitis superficial Deep vein thrombosis
Placebo (N=151) 14 (9.3) 0 9 (6.0) 5 (3.3) 5 (3.3) 0 2 (1.3) 0
Varithena® 1.0% (N=149) 25 (16.8) 24 (16.1) 23 (15.4) 18 (12.1) 16 (10.7) 12 (8.1) 8 (5.4) 7 (4.7)
Pooleda Varithena® (N=437) 65 (14.9) 46 (10.5) 38 (8.7) 32 (7.3) 30 (6.9) 24 (5.5) 40 (9.2) 10 (2.3)
a Includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials. b Retained coagulum. c Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).
In the 1333 patients treated with Varithena®, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius and soleal vein thrombosis (1.4%).
Since Varithena® induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena®. Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena® trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group and 4.0% in the placebo groups. Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group and 0.7% of the placebo group in the placebo-controlled studies. DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with Varithena®. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of Varithena® in pregnant women. Do not use Varithena® during pregnancy. Labor and Delivery The effects of Varithena® on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena®, is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering Varithena® to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Of the 1333 subjects in clinical studies treated with Varithena®, 9.1% (n=121) were ≥65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies. OVERDOSAGE There are no known cases of overdosage with Varithena®. In clinical studies, total volumes of up to 60 mL of Varithena® per treatment session have been administered.
Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. 115 Hurley Road, Building 3, Oxford, CT 06478 Provensis Ltd, Biocompatibles UK Ltd, and Biocompatibles, Inc. are BTG International group companies Varithena is a registered trademark of Provensis Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd
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NEWS Cardiologist wins 100K BSN-JOBST research grant at AVF annual meeting Yogendra M. Kanthi, M., a cardiologist and vascular medicine specialist at the University of Michigan, is the 2017 recipient of the BSN-JOBST $100,000 Research Grant. BSN has contributed to important independent research in venous and lymphatic diseases through this grant for the past 21 years. In 1995, BSN, in association with the American Venous Forum (AVF), initiated the research grant to further Conrad Jobst’s legacy of innovation. The Fellowship, which has helped to jump-start the careers of young investigators, is designed to provide a foundation of research to build on future work and grants for mentored and independent research. Recipients are asked to submit a oneyear update and present a progress report to the AVF membership at its Annual Meeting. BSN increased the research grant from $50,000 to $100,000 in 2015. “Advancement in the understanding and treatment of vein disease would not be possible without the pursuit of scientific research,” said Marc A. Passman, MD, president of the AVF. “The prestigious BSN-JOBST Research Grant has enabled numerous grant recipients to perform critical vein disease research and collect data that has helped the medical community to better understand venous and lymphatic diseases. The AVF and the AVF Foundation are extremely grateful to BSN medical for their continued generosity and commitment to clinical research.” For his research, Dr. Kanthi will investigate the mechanisms that may impede the development of deep vein thrombosis (DVT). The rationale for the proposed work is to develop novel, safe and easily translatable therapeutic strategies that can temper venous thrombo-inflammation to prevent immediate and long-term complications. Dr. Kanthi will work under the mentorship of David J. Pinsky, MD, and Peter K. Henke, MD, from the University of Michigan. Felix Dahm, MD and executive vice president of Innovation and Strategic Development for BSN medical, said BSN medical is proud to support these scientific discoveries and advancements through the BSN-JOBST Research Grants. “The idea of potentially finding a therapeutic solution for venous disease that can improve the lives of patients is what drives BSN’s continued commitment to medical science and research.” The selection for the recipient of the BSN-JOBST Research Grant is performed through a competitive peer review process. The competition is open to residents, fellows in a vascular training program, as well as physicians who have completed their training
within the past five years. Dr. Kanthi was awarded the BSN-JOBST Research Grant at the AVF’s 29th Annual Meeting in New Orleans. VT N READ MORE: bsnmedical.com
which examined the use of the Tack device to repair dissections in tibial arteries following PTA. The data showed 78.4 percent patency after 12 months and a 93.5 percent freedom from re-intervention. VT N
BTK clinical trial tests Tack endovascular system
Velano raises $17M for needle-free blood draw device
Intact Vascular has launched the Toba II BTK clinical trial to evaluate the safety and efficacy of its Tack endovascular system along with standard balloon angioplasty for treating critical limb ischemia in the popliteal and tibial arteries. CEO and President Bruce Shook said it enrolled the first patient in the trial at Yuma, Ariz.’s Yuma Regional Hospital and Heart, Lung and Vascular Center. The first patient in the trial was treated by Joseph Cardenas, MD. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Intact Vascular said. “One of our key goals when we perform angioplasty in patients with CLI is to restore blood flow to the foot, and keeping the treated arteries open over time is a major challenge,” Dr. Cardenas said. “The Tack system is uniquely designed to repair dissections following angioplasty while minimizing arterial inflammation and leaving little foreign material behind. “I believe this represents an ideal combination for maintaining long-term arterial patency. The Toba II BTK trial will provide us with valuable information about this very promising technology designed to optimize angioplasty results in CLI. Shook said the 232-patient prospective Toba II BTK trial is the first industry sponsored pivotal clinical trial approved by the FDA to explore the use of permanent vascular implants in arteries below the knee. “Patients with CLI have significant comorbidities and an increased risk for amputation, yet they have very few treatment options,” Shook said. “The commencement of the Toba II BTK trial represents an exciting step toward making the Tack Endovascular System available as new endovascular treatment for this debilitating disease.”. In January, Intact Vascular announced it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle. The CE Mark was supported by data from the company’s TOBA BTK clinical trial,
Velano Vascular has raised $17 million from new and existing investors for its Pivo needle-free blood draw device. The San Francisco, Calif.-based company said it has also won FDA clearance for its second version of the PIVO needle-free vascular access device. The disposable device helps to gather blood samples from indwelling peripheral IVs, helping to avoid extra needle sticks and not using central lines to draw blood. The Velano Pivo device is a single-use disposable product designed to collect blood from indwelling peripheral IV lines, reducing the need for needle sticks and central line access for blood collection. The PIVO has a catheter that is placed into the peripheral IV and pushed down into the blood vessel, through which blood is pulled back into PIVO’s reservoir. It doesn’t have any needles, reducing the potential for injuries to the staff and repeated needle sticks for the patient, including all the consequences these events can introduce. The new device has been made to be gentler on the patient while making the manufacture of it easier and cheaper, helping to promote its adoption. “Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” in a statement said Anna Kiger, DNP, D.Sc., MBA, R.N., Sutter Health Chief Nurse Officer “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.” The device is already in use in a few hospitals around the country, with general distribution expected later this year thanks to the newly issued clearance. The company plans to use the new funding to scale and commercialize a family of vascular access technologies, including the Pivo device. “This level of investment is a tremendous validation of our team’s effort to establish a true, more compassionate standard of care,” CEO Eric Stone said in prepared remarks. “Tens of thousands of PIVO draws across multiple health systems in the United States. and overseas reflect that there is a better, more efficient way to draw blood. This funding will allow us to meet the growing commercial demand and to touch millions of lives in the years ahead.”
An unnamed publicly traded healthcare company and global supplier invested in the round, joining First Round Capital, Griffin Hospital, Kapor Capital, Safeguard Scientifics, Sutter Health, The Children’s Hospital of Philadelphia, White Owl Capital and others, according to the company. “Our ongoing investments in Velano are driven by our belief that this revolutionary technology addresses a significant unmet need supported by mounting market demand,” White Owl Capital managing director David Mars added. “It also provides a rare opportunity to work with an inspiring team of patient-centered innovators and a company that will positively impact millions of patients and caregivers around the world.” In February, the company won 510(k) clearance from the FDA for its needle-free device. VT N READ MORE: velanovascular.com/solutions/
Clot management report aids study Research and Markets has announced the addition of the “North America Clot Management Devices Market (2016-2022)” report to its offering. North America captures maximum share of the clot management devices market with the high acceptance of technologically advanced products coupled with higher awareness among the customers. According to the World Health Organization (WHO), more than 17 million people die annually from cardiovascular diseases. The main reason for cardiovascular diseases are increasing consumption of tobacco products, physical inactivity, changes in diet plans, air pollution and work pressure. Blood clotting, also known as coagulation, is the body’s response to an injury to prevent bleeding. However, a clot can be harmful when it results in abnormal flows through the vessels. The excessive formation of clots in the blood leads to different diseases such as brain stroke, heart attack and severe leg pain. VT N READ MORE: researchandmarkets.com/ research/wqlqh5/north_america
APRIL/MAY 2017 < VEIN THERAPY NEWS
SEGMENTAL PROCEDURES. CONSISTENT RESULTS. Step-wise, targeted procedures for reproducible venous treatments VenaSeal
closure rate at 2 years1
closure rate at 5 years2
www.varithena.com References: 1. Kolluri, Raghu: VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) 24 Month Results at Charing Cross, April 26, 2016. 2. Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. The British Journal of Surgery. Feb 2015;102(3):212-218.
UC201710164 EN © 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 02/2017
NEWS Medtronic adds to coronary portfolio Medtronic unveiled three new additions to its coronary portfolio in February – a transradial diagnostic catheter and accompanying transradial devices – to facilitate the treatment of coronary artery disease via the radial artery in the wrist. Medtronic announced that it was launching the DxTerity Diagnostic Angiography Catheter line and a suite of transradial products, including an access kit and compression device. The diagnostic catheters are used to ascertain whether a patient will need revascularization – bypass or angioplasty – to
treat their coronary artery disease. Meanwhile, the InTRAkit access kit includes components such as ergonomic needles and tapered introducer sheaths to improve the transradial procedure. The TRAcelet compression device simplifies pressure control at the access site. Percutaneous coronary intervention (PCI) is a nonsurgical procedure to treat the narrowing of coronary arteries. While PCI usually involves balloon angioplasty to compress plaque against the wall of the artery, the physician may also deploy a stent to keep the artery open. It is usually done through the femoral artery or the radial artery. “The global approval of the DxTerity Diagnostic Catheters, as well as the introduction of the new Medtronic suite of transradial products represents a
significant step forward for patients requiring PCI procedures,” said Dr. Sunil Rao, an interventional cardiologist and associate professor of medicine at Duke University. “It’s increasingly important to have a full suite of products accompanied by robust training to increase physician utilization, improve patient comfort and enable same-day discharge.” Medtronic is also launching an education and training tool for physicians, staff and administrators dubbed the Transradial Arc Curriculum in the United States. It is designed to provide clinical training to help hospitals improve their delivery of transradial care, said Jason Weidman, vice president and general manager of Medtronic’s coronary and renal denervation business.
“Our new line of comprehensive transradial products and programs that support PCI from start to finish were developed to meet the evolving clinical and health economic needs of physicians, administrators and cath lab teams around the globe,” he said. “Our intent with these recent innovations in our premium product portfolio is to help accelerate adoption of the transradial approach so that more patients and hospitals may experience the advantages transradial access can bring.” VT N R EAD MORE: researchandmarkets.com/ research/642phf/europe_venous
Intended Use/Indications: The VenaSeal closure system (VenaSeal™ system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS). Contraindications: Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis exists. Potential Adverse Effects of the Device on Health: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the VenaSeal system. The adverse events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock, arteriovenous fistula, bleeding from the site of access, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, infection at the access site, non-specific mild inflammation of the cutaneous and subcutaneous tissue, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria or ulceration may occur at the site of injection, vascular rupture and perforation, visible scarring. Warnings, precautions, and instructions for use can be found in the product labeling. For VenaSeal, this labeling can be found at http://useifu.venaseal.com.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. DC00037656
Aortic | Peripheral | endoVenous 3033 Campus Drive, N550 Plymouth, MN 55441 USA
Orders Toll free: +1.800.962.9888 Fax: +1.800.734.1324
24-hour Technical Support Toll free: +1.800.328.2518
endoVenous Customer Service Toll free: +1.800.842.6410
medtronic.com/endovenous http://www.medtronic.com/endovenous 10
CardioVascular LifeLine Customer Support Tel: +1.763.526.7890 Toll free: +1.877.526.7890
APRIL/MAY 2017 < VEIN THERAPY NEWS
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The acquisition brings a portfolio of more than 90 coronary and peripheral vascular devices under the Teleflex umbrella. Teleflex is the home of brands Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch and Weck. Owners of some 77.6 percent of the nearly 17.6 million Vascular Solutions shares participated in the Feb. 16 meeting, with 13.5 million or 99.2 percent voting to approve the merger. A vote on compensating executives passed on a 91.9 percent vote, at 12.5 million shares. In January, a group of shareholders sued to block the merger, arguing that the deal undervalues Vascular Solutions and locks out any competing bids. The purported class action, filed Jan. 27 in the U.S. District Court for Minnesota, alleges that the $56-per-share Teleflex deal is an “inadequate consideration” for Vascular Solutions. The sale came a year after Vascular Solutions and its founder and CEO Howard Root were found not guilty in a brutal criminal prosecution related to alleged “off-label” promotion of its varicose veins treatment, Vari-Lase Short Kit. Vascular Solutions went toe-to-toe with the U.S. Justice Department for five years and walked away with a win. Shares of Vascular Solution nearly doubled after the company and Root was exonerated in February. But the fight exacted a price for Root and the company he built. “Following the jury verdict in February …I am not willing to assume much longer the personal risk associated with being the CEO of a public medical device company,” Root said Dec. 2, 2016, when the definitive agreement was announced. Vascular Solutions is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of more than 90 products and services that are sold to vein specialists, interventional cardiologists, interventional radiologists, and electrophysiologists through its direct U.S. sales force and international independent distributor network. VT N
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CVC segment growth detailed Growth in the value of the acute central venous catheters (CVCs) segment is expected to apply upward pressure to the value of the total CVC market through 2020. According to a report by Research and Markets, decreases in the chronic CVC segment will moderate gains in the value of the total CVC market. The total U.S. market for CVCs comprises acute CVCs and chronic CVCs. VT N
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VEIN THERAPY NEWS < APRIL/MAY 2017
NEWS Cleveland Clinic, Atrius uses IBM Watson, cognitive computing to fight physician burnout Concern about physician burnout has remained consistently high among healthcare leaders, but organizations have relatively few effective tools with which to address the problem. Now, major healthcare industry players are turning to cognitive computing to help them fight physician burnout. Pointing to a pair of high-profile collaborations with IBM Watson by the Cleveland Clinic and Atrius Health, an article in HealthData Management makes the case for cognitive computing as a vital tool for improving efficiency and quality of care. Even where administrations seek to encourage better work-life balance and social support, the shifts in care delivery after the passage of the Affordable Care Act have frequently caused clinicians to feel more isolated and overwhelmed. The rise of cognitive computing, where artificial intelligence systems receive training to assist clinicians in synthesizing and navigating huge amounts of data, offers potential for relieving some of the stress physicians face, according to William Morris, MD, associate chief information officer at the Cleveland Clinic, in a HealthData Management article. He emphasized that his organization’s partnership with IBM Watson aims to “augment the clinical thought process, not to replace it.” This is an important distinction for physicians leery of having their independence supplanted by technology, as IBM CEO Ginni Rometty noted in her keynote speech at the 2017 HIMSS conference in February. Joe Kimura, MD, chief medical officer of Atrius Health in Boston, sees technology as a critical tool for physicians navigating an increasingly unwieldy amount of medical information. “You feel guilty if you’re not processing all the data to make good decisions for your patients,” he told the publication. Concern about physician burnout has remained consistently high among healthcare leaders, but organizations have relatively few effective tools with which to address the problem. Now, major healthcare industry players are turning to cognitive computing to help them fight physician burnout. Pointing to a pair of high-profile collaborations with IBM Watson by the Cleveland Clinic and Atrius Health, an article in HealthData Management makes the case for cognitive computing as a vital tool for improving efficiency and quality of care. Even where administrations seek to encourage better work-life balance and social
support, the shifts in care delivery after the passage of the Affordable Care Act have frequently caused clinicians to feel more isolated and overwhelmed. The rise of cognitive computing, where artificial intelligence systems receive training to assist clinicians in synthesizing and navigating huge amounts of data, offers potential for relieving some of the stress physicians face, according to William Morris, M.D., associate chief information officer at the Cleveland Clinic, in a HealthData Management article. He emphasized that his organization’s partnership with IBM Watson aims to “augment the clinical thought process, not to replace it.” This is an important distinction for physicians leery of having their independence supplanted by technology, as IBM CEO Ginni Rometty noted in her keynote speech at the 2017 HIMSS conference in February. Joe Kimura, MD and chief medical officer of Atrius Health in Boston, sees technology as a critical tool for physicians navigating an increasingly unwieldy amount of medical information. “You feel guilty if you’re not processing all the data to make good decisions for your patients,” he told the publication. VT N
FDA warns of MACE event risk with Absorb BVS The FDA is investigating the significant increase in major adverse cardiac events (MACE) seen for the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular) vs everolimus-eluting metal stent (Xience, Abbot Vascular) in 2-year data from the ABSORB 3 trial, the agency said in a letter to clinicians. It approved the novel BVS scaffold in July 2016. The trial saw an 11 percent increase in the composite of cardiac death, M, or repeat revascularization (P=0.03) over 2 years in patients who received the Absorb scaffold vs Xience, the agency pointed out, and was presented in mid-March at the American College of Cardiology (ACC) 2017 Scientific Sessions. According to the presentation, the risk seems to be concentrated in the cases that used smaller-caliber Absorb scaffolds, which have not been recommended. The take-home message, said ABSORB 3 investigators, is that the BVS should be avoided in smaller coronary vessels. The FDA noted that the findings that had emerged at 2 years “are consistent with the trends observed in the recently published 3-year results from the ABSORB 2 study and the recently presented 2-year results from the ABSORB Japan study.” Both studies, conducted outside the United States, as
reported at TCT 2016 and covered then by heartwire from Medscape. According to the FDA, clinicians should “follow the instructions for target heart vessel selection (eg, avoiding BVS use in small heart vessels) and optimal device implantation in the scaffolds labeling. “The FDA is working with Abbott Vascular to conduct additional analyses to better understand the cause(s) of the higher cardiac event and device thrombosis rates in patients treated with BVS compared with the XIENCE stent. The FDA will continue to monitor the performance of the BVS in ongoing clinical studies and in reports submitted to FDA through MedWatch.” VT N
OCR auditing risk management and implementation Consider yourself warned. The HHS Office for Civil Rights will be conducting a “small number” of onsite HIPAA audits this year, and they are looking for, among other things, implementation of risk analysis and risk management. OCR senior adviser Linda Sanches explained what healthcare leaders can expect from the process. “We’re looking for evidence that you are implementing the policies and procedures,” Sanches explained. “Two huge problems we’re seeing are implementation of risk analysis and risk management.” HIPAA privacy audits were put on hold last year as the agency developed its phase 2 policy. Then in the spring, HHS posted a new HIPAA audit protocol, according to OCR Director Jocelyn Samuels. OCR will look “at risk analyses and risk management, notices of privacy practices and access and response to requests for access, and content timeliness of notifications,” Samuels said. Sanches said that more than 200 desk audits are going on now, and most of them are focused on providers. VT N
Trump urges drug manufacturers to reduce prices President Donald Trump maintained a pledge he kept throughout his election campaign and told big pharmaceutical companies in February they must make prescription drugs more affordable. “The U.S. drug companies have produced extraordinary results for our country but the pricing has been astronomical for our country,” Trump said during the meeting with pharmacy industry leaders. Although he specifically pointed out the need to drop Medicare and Medicaid drug
prices, Politico reported he also appeared to suggest that Medicare, which is banned from negotiating with drugmakers, hurts competition, “I’ll oppose anything that makes it harder for small, younger companies to take the risk of bringing a product to a vibrantly competitive market,” Trump said, according to the Politico report. “That includes price fixing by the biggest dog in the market, Medicare, which is what’s happening. But we can increase competition and bidding wars big time – we have to – into that program.” In addition, Trump pledged to decrease Food and Drug Administration regulations to get drugs to the market faster and help bring back manufacturing jobs to the U.S. Most of the meeting was held behind closed doors, but Trump spoke to the media before the meeting and introduced the executives and representatives from pharmaceutical companies and organizations. Among those in attendance: executives from Merck & Co., Johnson & Johnson, Celgene Corp., Eli Lilly & Co., Amgen and Novartis AG, as well as Stephen J. Ubl, president and chief executive officer of the lobbying group Pharmaceutical Research and Manufacturers of America, or PhRMA, who described the meeting with Trump as “positive” and “productive.” In a statement, Ubl said the group discussed the need to advance stronger trade agreements, reform the tax code to spur investment and job creation, and remove outdated regulations that drive up costs and slow innovation. He said that if the policies are enacted, it could result in up to 350,000 new jobs over the next 10 years. Celgene, Lilly, Merck and Amgen also told Reuters by email that they were encouraged by Trump’s focus on innovation, tax reform and the need for a more value-driven healthcare system. VT N
Report details peripheral nerve block analysis Research and Markets has added “Continuous Peripheral Nerve Block Catheter Market: Global Industry Analysis and Opportunity Assessment, 2016-2026” report to its offering. This report examines the continuous peripheral nerve block catheter market for the period 2016-2026. The primary objective of the report is to offer updates and in-depth analysis of market opportunities in the global continuous peripheral nerve block catheter market. VT N READ MORE: researchandmarkets.com/ research/hdp4hs/continuous
APRIL/MAY 2017 < VEIN THERAPY NEWS
NEWS APPROVED BY FDA • 87% PATIENT SATISFACTION VS. 64% WITH STS*
High satisfaction and success ratings, with fewer side effects as compared to STS.
Now that’s a beautiful thing.
Not an actual patient Asclera® (polidocanol) Injection not only has a 12-week patient satisfaction rate of 87%, but also a proven success rate—with 95% of patients showing “good improvement” or “complete treatment success.”*
JOIN US AT IVC FOR OUR LUNCH SYMPOSIUM Compounded Sclerosants: A review of safety, economic and legal perspectives Friday, April 21 at noon See full Prescribing Information for data.
INDICATIONS: Asclera (polidocanol) Injection is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. IMPORTANT SAFETY INFORMATION: For intravenous use only. CONTRAINDICATIONS: Asclera (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Accidental injection into an artery can cause severe necrosis, ischemia, or gangrene. If this occurs, consult a vascular surgeon immediately. Inadvertent Perivascular Injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.
VEIN THERAPY NEWS < APRIL/MAY 2017
Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and the smallest effective volume at each injection site should be used. After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reactions. Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, neovascularization, injection site thrombosis. Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein 13 thrombosis.
NEWS Asclera® (polidocanol) Injection Rx Only BRIEF SUMMARY. PLEASE CONSULT FULL PRESCRIBING INFORMATION PRIOR TO ADMINISTRATION. INDICATIONS AND USAGE: Asclera (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. DOSAGE AND ADMINISTRATION: For intravenous use only. The strength of the solution and the volume injected depend on the size and extent of the varicose veins. Extensive varicosities may require multiple treatment sessions. Uncomplicated spider veins (varicose veins ≤ 1 mm in diameter): Use Asclera 0.5%. Uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter): Use Asclera 1%. Use 0.1 to 0.3 mL for each injection into each varicose vein. Do not use more than 10 mL per session (see Dosage and Administraion  of Full Prescribing Information). Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. DOSAGE FORMS AND STRENGTHS: Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules. CONTRAINDICATIONS: Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. WARNINGS AND PRECAUTIONS: Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site. After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction (see Dosage and Administration  of full prescribing information). Accidental Intra-arterial Injection: Intra-arterial injection can cause severe necrosis, ischemia, or gangrene. If this occurs consult a vascular surgeon immediately. Inadvertent Perivascular Injection: Inadvertent perivascular injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected. ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera and were more common with Asclera than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, and injection site thrombosis (see Adverse Reactions  of Full Prescribing Information). To report SUSPECTED ADVERSE REACTIONS, contact Merz Aesthetics, Inc. at 1-866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. POST-MARKETING SAFETY EXPERIENCE: The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases, these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness
Cardiac disorders: Cardiac arrest, palpitations Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic, and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning, and procedural complications: Nerve injury USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Asclera should not be used during pregnancy. Animal Studies: Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg. Human Studies: There are no adequate and well-controlled studies on the use of Asclera in pregnant women. Labor and Delivery: The effects of Asclera on labor and delivery in pregnant women are unknown. Nursing Mothers: It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman. Pediatric Use: The safety and effectiveness of Asclera in pediatric patients have not been established. Geriatric Use: Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. OVERDOSAGE: Overdose may result in a higher incidence of localized reactions such as necrosis. HOW SUPPLIED/STORAGE AND HANDLING: Asclera is supplied in single-use, preservative-free ampules in the following packages: NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30°C; (59-86°F). PATIENT COUNSELING INFORMATION: Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days. For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot bath or sauna.
AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Asclera is a registered trademark of Chemische Fabrik Kreussler & Co., GmbH. © 2017 AngioDynamics, Inc. ANGAD 436 US Rev 01 03/17
APRIL/MAY 2017 < VEIN THERAPY NEWS
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NEWS ACP MOBILIZES
In order to provide direction and maintain a consistent message to cover the main concerns of the policy, a list of specific objections were provided to be included in their comments, and individuals submitting comments were urged to use their own unique voice. In addition, key medical literature references, a sample letter and information on how to submit comments were also provided to support their efforts. This communication went out three separate times to membership, which generated numerous calls, emails, and inquiries to the ACP headquarters staff, who provided support to our members’ comment efforts.
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On Jan. 19, Novitas Inc. released a proposed a draft Local Coverage Determination (LCD) regarding treatment of varicose veins of the lower extremities. Novitas is a Medicare Administrative Contractor (MAC) for the Centers for Medicare and Medicaid Services (CMS) and is responsible to administering jurisdiction J-H, which includes: Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania and Texas.
POLICY LIMITATIONS AND KEY CONCERNS
The Novitas LCD on varicose veins threatens to restrict coverage to a large number of Medicare beneficiaries for symptomatic venous insufficiency. The changes in the proposed LCD are a significant departure from prior Novitas policies and current LCDs from other MACs, as well as all commercial insurance carriers. The proposed policy is not consistent with published society guidelines or scientific literature, and will limit a patient’s access to appropriate medical care within those affected areas.
ACP TAKES ACTION TO MOBILIZE MEMBERS AND COMMUNITY
In response to the Novitas policy, the ACP took immediate action in formally objecting to the proposed policy. Seven days after the policy was released, an open meeting was held at the Novitas office in Mechanicsburg, Penn., on Jan. 26. Despite the short notice, an ACP physician member in the local area was contacted by the ACP Executive Committee and the policy concerns were reviewed and discussed in detail. That member then attended the meeting to represent the ACP and provided expert testimony to the Novitas panel. This testimony was given to one Novitas medical director who hosted the meeting, along with several other medical directors who were present via conference call. The ACP’s representative discussed several key points during his brief presentation, including existing treatment based guidelines, how the policy differs widely in criteria from other MACs, and specific issues with the policy. Following this meeting and through the wide range of contacts facilitated by the Alliance of Wound Care Stakeholders, the ACP had an opportunity to inform a member of the Novitas Mid-Atlantic Carrier Advisory Committee (CAC) of our concerns with the draft LCD prior to their meeting that occurred on Feb. 15. During this discussion, the member of the CAC provided a general overview of the public health perspective and policy drafting process. ACP representatives were then able to address their concerns, voice their recommendations and present evidence to the member of the CAC, with the hope that those concerns would be compelling enough to be presented during the Mid-Atlantic CAC meeting. On the joint venous community front, numerous discussions ensued to gain perspective and begin to open connections for a joint society consortium to publicly oppose the Novitas policy. Several face-to-face meetings occurred with society leaders and industry during the American Venous Forum’s (AVF) Annual Meeting in New Orleans in February. The collaborative efforts of leadership from the ACP, AVF and SIR during and
after the AVF meeting led to a written public comment to Novitas, which was initially drafted by the ACP and contributed to by members of several other societies. Following multiple iterations, a final public comment was agreed upon and countersigned by seven separate societies representing more than 16,000 physicians who treat patients with venous disease. These societies included the ACP, the AVF, the Society for Vascular Medicine (SVM), the Society for Vascular Surgery (SVS), the Society of Interventional Radiology (SIR), the Society for Cardiovascular Angiography and Interventions (SCAI) and Vascular Interventional Advances (VIVA Physicians). The primary request in this comment was to have Novitas completely withdraw the proposed policy. In addition, the coalition addressed their most important concerns, offered recommendations for alternatives, and provided the full text version of each supporting piece of evidence. The coalition also offered Novitas volunteer content experts from our societies who could work with the policy writing team to develop policies that both adhere to medical evidence, but also are respectful of protecting the resources of our shared Medicare trust. The unprecedented collaboration across this number of societies demonstrated that the entire Venous and Lymphatic community can come together with a single voice to advocate for patient care. The consortium’s public comment was submitted directly to Novitas on March 9, and the ACP provided essential leadership and administrative support to augment the consortium’s efforts. The ACP also submitted its own written comment directly to Novitas, which publicly supported the seven-society consortium, and reinforced the request to withdraw the policy entirely based on the fact that many of the proposed LCD changes have no supporting medical evidence, arbitrarily limit access to care for patients with clinically significant disease and have the potential for serious patient health consequences. Knowing the importance of strength in numbers, the ACP concurrently began its membership mobilization efforts by urging members in the affected jurisdictions to have their voices heard. A member communication was sent out by email providing background information on the policy and urging members to make public comments in opposition of the policy. We enthusiastically supported other organizations that wanted to share this message with their membership as well.
Following the close of the open public comment period on March 9, the ACP continues to pursue advocacy activity in opposition of the Novitas policy. Moving forward, the ACP encourages members in the affected regions to contact their local congressmen and senators regarding the proposed LCD, and has a sample letter available to support that effort. In addition, the ACP also encourages members to get their patients involved in the discussion, and has a list of credible discussion boards for their patients to post to in order to have their voices heard. On March 15, a separate group conducting advocacy activities on this matter met with a health policy advisor for Congressman Kevin Brady of the U.S. House of Representatives. Rep. Brady represents Texas, and is the chairman of the House Ways and Means Committee, which oversees several federal agencies including CMS. To support this activity, the ACP drafted a petition letter in support of the ACP constituents in Texas that was provided directly to the health policy advisor. Many of our Texas members requested to be included on the petition letter, and this grassroots effort allows the society to voice the cumulative voice of our members within that impacted jurisdiction. The ACP Leadership has also reached out directly to the American Association of Retired Persons (AARP) and the Alliance for Patient Access in an attempt to secure a voice from affected Medicare patient populations – another attempt to garner resources to help prevent this draft policy from being adopted. The ACP leadership along with the leadership of the other organizations of the coalition has requested a meeting with the Novitas medical directors. The intent is to further discuss the draft policy, its effect on patient care and the evidence base, and formally request that the policy be withdrawn. We have also been involved in directly speaking with the staff of various members of the legislative branch to ask for help in voicing our concerns about the potential risks for patients if this policy is enacted.
Many individuals have been instrumental in supporting the ACP’s mobilization efforts, providing guidance, and contributing to the collaboration in preparing the joint opposition statement. From the ACP: Dr. Neil Khilnani, Dr. Marlin Schul, Dr. Robert Worthington-Kirsch, Dr. Stephen Daugherty, Dr.
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NEWS Video: Mayo hits ‘tipping point’ with Medicare Mayo Clinic CEO Dr. John Noseworthy is under fire after telling employees of the Rochester, Minnesota-based health system they should “prioritize” treating patients with commercial insurance over those with Medicare or Medicaid if their conditions are the same. In a 2016 videotaped speech to employees, of which the Star Tribune obtained a transcript, Dr. Noseworthy said, “We’re asking…if the patient has commercial insurance, or they’re Medicaid or Medicare patients and they’re equal, that we prioritize the commercial insured patients enough so…we can be financially strong at the end of the year to continue to advance, advance our mission.” Addressing employees, Dr. Noseworthy said that the Mayo Clinic had reached a “tipping point” with a 3.7 percent increase in Medicaid patients. He cautioned that without balancing out the number of commercially insured patients, Mayo’s finances would suffer. “If we don’t grow the commercially insured patients, we won’t have income at the end of the year to pay our staff, pay the pensions, and so on, so we’re looking for a really mild or modest change of a couple percentage points to shift that balance,” he said. In 2016, Mayo Clinic, which sees more than 1.3 million patients annually, reported net operating income of $475 million. The same year, the health system also said it provided $629.7 million in care to individuals in need, including $83.3 million in charity care and $546.4 million that wasn’t covered by Medicaid or other programs that care for the uninsured or underinsured. Then Dr. Noseworthy released a statement in response to the Star Tribune article: “Patient medical need will always be the primary factor in determining and setting an appointment. In an internal discussion I used the word ‘prioritized’ and I regret this has caused concerns that Mayo Clinic will not serve patients with government insurance. Nothing could be further from the truth. In fact, about half of the total services we provide are for patients who have government insurance, and we’re committed to serving those patients. “Changing demographics, aging of Americans and budgetary pressures at state and federal government pose challenges to the fiscal sustainability in healthcare today. While these discussions are uncomfortable, they are critical for us to be able to meet the needs of all our patients.” But in his speech, first reported by Minnesota’s Star Tribune, Noseworthy cited the recent 3.7 percent rise in Medicaid patients as a “tipping point” for the organization. Many
government payer programs tend to pay lower reimbursement rates than commercial insurers for patients treated for similar conditions. Minnesota Department of Human Services Commissioner Emily Piper told the Star Tribune the department will be examining whether Mayo violated patients’ rights or its Medicaid contracts with the state. VT N
Corindus raises $45M, misses projection by a cent Corindus Vascular Robotics closed a $45 million offering in mid-March and 4th quarter and fiscal year 2016 earnings, which just missed expectations on Wall Street. In the offering, Waltham, Mass.-based Corindus floated an aggregate of 68.1 million shares of common stock at 66 cents per share, with proceeds intended to support general corporate purposes as well as commercialization of its next-gen CorPath GRX system. As part of the funding round, Louis Cannon MD, of the Cardiac & Vascular Research Center of Northern Michigan was appointed to the company’s board of directors. “Corindus will play a major transformational role in cardiac and vascular intervention,” Dr. Cannon said in a release. “This technology reduces procedural variability, physician fatigue and radiation exposure, especially in lengthy procedures. Robotics also has the future potential to treat strokes and heart attacks tele-robotically. If we can treat patients tele-robotically from hospital centers of excellence, we can impact humanity in a truly meaningful way, especially in geographic areas that lack the required physician expertise.” Corindus saw shares slump St. Patrick’s Day after it released Q4 and FY2016 earnings which missed expectations on Wall Street. The company posted losses of $9.8 million, or 8 cents per share, on sales of $538,000 for the three months ended Dec. 31, with losses growing 35.4 percent while overall sales shrunk 35.3 percent compared with its prior 4th quarter. For the full year, Corindus posted losses of $33.1 million, or 28 cents per share, on sales of $2.8 million. Bottom-line losses grew 15 percent while sales grew 4.1 percent compared with the previous fiscal year. For both the quarter and the year, the company missed its losses-per-share expectations by 1-cent. “Corindus is better positioned today than ever in the company’s history, aligning with the evolution in the cardiology sector, which is poised to more fully incorporate robotics into practice than ever before,” CEO Mark Toland said in a prepared statement. Toland said the first commercial cases with the CorPath GRX at prestigious U.S.
hospitals, the recent receipt of several multisystem orders, and our recent expansion into Japan demonstrate meaningful continued progress toward our strategic and commercial objectives. “Our leadership team is solidly in place, and we are benefiting from the deep and broad experience of our collective team. With the recent financing, which brought approximately $45 million in aggregate gross proceeds to the company, we are excited to accelerate our already strong positive momentum into 2017 and deliver on our expectation to implement at least 25 new cardiovascular programs and reach $13 million to $15 million in revenue for the year,” Toland said. VT N
PVD pipeline data released through 2020 The most up-to-date information regarding global peripheral vascular disease key pipeline products is available in a new report from Research and Markets titled “Peripheral Vascular Disease Pipeline Highlights – 20172020.” It covers emerging therapies for peripheral vascular disease (PVD) in active clinical development stages including early and late stage clinical trials. The pipeline data presented in this report helps executives tracking competition, identifying partners, evaluating opportunities, formulating business development strategies, and executing in-licensing and out-licensing deals. The report provides PVD pipeline products by clinical trial stages including both early and late stage development: phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research and discovery stage. It also provides PVD pipeline products by their dominant mechanism of action. This helps executives categorize products based on their drug class and also assess the strengths and weaknesses of compounds. In addition, it provides PVD pipeline products by the company, and by date of launch through 2020. VT N READ MORE: researchandmarkets.com/ research/bkq9x7/peripheral
Technavio offers report on PVD analysis worldwide According to the latest market study released by Technavio, the global peripheral vascular diagnostic systems market is expected to grow at a CAGR of more than 7 percent during the forecast period.
This research report titled “Global Peripheral Vascular Diagnostic Systems Market 2016-2020” provides an in-depth analysis of the market in terms of revenue and emerging market trends. This market research report also includes up to date analysis and forecasts for various market segments and all geographical regions. Deposition of plaque in arteries that carry blood to any body part other than the heart is called peripheral artery disease (P.A.D.). P.A.D. is directly linked to cardiovascular disease (CVD) and diabetes. Owing to unhealthy lifestyles, the number of P.A.D. cases are increasing, driving the demand for peripheral vascular diagnostic systems. To increase diagnostic efficacy, vendors are manufacturing Doppler ultrasound systems and plethysmography devices. The market penetration of these devices is set to increase with vendors introducing novel technologies that minimize the need for follow-up visits to the physician. The market is likely to witness maximum growth in developing countries during the forecast period where awareness about P.A.D. and its treatment is increasing. VT N To request a free sample report, see technavio.com/request-asample?report=54785
Study examines physician divide on EHR issues Electronic health records have benefits for patients and physicians, but they also raise ethical concerns. EHRs should facilitate patient care and strong patient-physician relationships, the American College of Physicians (ACP) said in a new position paper published in the Journal of General Internal Medicine. “Electronic health records can aid in the delivery of high quality care to patients. However, health information technology also poses unintended ethical concerns that the medical profession must examine and address,” Nitin S. Damle, MD, ACP president, said in an announcement. Doctors are divided about whether the physician community should embrace EHRs, with some urging widespread adoption to improve care and others lamenting the administrative burden that results. A big concern is the effect on the physicianpatient relationship, since one recent study found doctors may spend up to three times as much time in front of a computer compared to face time with a patient. VT N READ MORE: EHR, Patient Engagement, Ethics, Privacy and Security, Physician Practice, American College of Physicians, Nitin Damle, Journal of General Internal Medicine
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GAME CHANGING STRATEGIES
Four ways to transform patient-centered care Reaching and engaging your population is one of the most challenging components of patient-centered care. Despite the challenges, there are compelling reasons to strive for engagement. Patient engagement has been defined in a variety of ways. Most now agree on this definition: The understanding of one’s role in the care process and having the knowledge, skill, and confidence to manage one’s health and health care and engaging in resulting behaviors such as obtaining preventive care or participating in regular physical exercise. To transform the patient experience into one that will lead to better outcomes, higher quality and lower costs, providers need to put the patient at the center of care. By educating and inspiring patients to act, providers can make a positive difference in patient behavior that occurs outside the clinic. Educated patients get multiple benefits from being engaged with their health and health care. Achieving the goals of improved quality, better outcomes and lower costs means engaging patients with trusted, consistent, evidence-based communication at every touchpoint on the care continuum: • Standardized yet personalized care Educational outreach opportunities include wellness visits, chronic care management and urgent care. • Care coordination It’s carried out by a dedicated team that shifts work away from physicians and can bridge care gaps by helping patients navigate their care, including education, providers and settings. • Online communication Provide educational resources (self-care videos, symptom checkers, drug interaction checkers, after hours contact information), self-assessment questionnaires, and decision aids through patient and marketing portals, texts, and social media. • Automated messaging Deliver real-time education to your patients wherever they are, whenever it’s convenient for them to interact with your practice, in a cost-effective way. Creating experiences that matter leads to engaged patients, which leads to outcomes that matter. In addition, improved patient engagement and the resulting positive outcomes drive higher job satisfaction in physicians. More satisfied doctors offer better and more thoughtful care, resulting in more satisfied patients and better outcomes8, which keeps the care continuum flowing. Four game-changing elements of a patient engagement strategy will transform your patients’ experiences.
Create standard care plans that improve the patient experience
Patient education is the foundation for building a successful patient engagement strategy and has a major effect on patient experience and satisfaction. Don’t leave this up to the whims of each clinician. Patients, their families, and clinicians all benefit when each provider has a consistent body of educational material to deliver at each visit. Patient education is even more powerful when it is consistent throughout your enterprise, so that wherever and however your
Providing evidencebased engaging educational resources
Helping patients to navigate providers
Helping to develop plain language care/ treatment plans
Providing benefit management support
Motivating patients to follow plans
Identifying specific populations and focusing on those that are high-risk or that suffer from chronic conditions
Identifying and helping to overcome psychological, social, financial and environmental barriers to treatment and engagement
Ensuring that electronic health records are up-to-date
Following up with patients in between Care episodes
Facilitating communication between team members
patients interact with your practice, they’ll receive the same health information every time.
STANDARD CARE PLANS
A large health system, looking for ways to expand patient education through existing platforms, came to Healthwise to explore their options. We mapped our education to the organization’s care plans to be delivered through their MyChart Bedside application. Combined with existing Healthwise videos and patient instructions, patient education now reaches across the organization’s populations to fill care gaps, reduce readmissions, improve outcomes and increase patient satisfaction. Building a personalized and standardized experience for every patient, using proven care plans and education, ensures that all patients are reached and have valuable experiences at every visit. You can train your staff to make the most of their interactions with patients, offering personal support, education, and information relating to: • Treatment options. • Provider choices and locations and appropriate care levels. • Prescription drug information. Standardized care plans can offer: • Reduced errors.
• Increased use of common language. • Improved communication. • Simplified work processes. • A user-friendly format. • Improved outcomes. And as the process of delivering standard care becomes more sophisticated, the care team can look for data coming back from the patient. Patient response data or patient-generated data can tell the care team if education and instructions have been opened and read. More importantly, patients become contributors to their own care, including treatment options, medical records, and short- and long-term care plans. This allows the care team to tailor care to the unique needs of individual patients and create personalized care plans that lead to quality outcomes, improved communication, and better and more user-friendly work processes. Think of standardized care plans as a two-sided coin –ß standard care plans aren’t effective without a standard of education in the care plans. Engage your patients with consistent, evidence-based education, delivered in plain language. Then receive response data from your patients that makes them contributors who inform your medical practice.
Create a care coordination team that’s based on a care team model
Care coordination allows the organization of patient activities and the sharing of information to all of the care team involved with a patient’s care. The care manager can send patient education that answers questions the patient may be reluctant to ask, gives greater understanding of symptoms and explains options for treatment. The entire care team has visibility into what was sent and opened by the patient. Shifting to a care team model that includes more nonmedical staff interacting with patients means being able to reach patients in between visits with education and care. It also means being able to identify and reach specific populations (e.g., high-spending, low-utilization, highrisk and chronic care) with education, treatment planning, benefit management support, healthy behavior reminders and utilization reporting. To shift coordination tasks away from medical providers, your team needs to be composed of medical and non-medical staff. Your entire multi-disciplinary team can then share expertise, knowledge and skill to solve the complex problems of coordinating patient-centered care. Specialists on the care team can use their expertise to shift coordination tasks away from physicians and engage patients by addressing behavioral changes and providing administrative support. Think of a care coordination team as creating a path within your organization’s workflow that moves some coordination work away from physicians and still delivers coordinated care at the right touchpoints to engage your patients. As a result of the
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SO, YOU HAVE A WEBSITE?
Tips to optimize your digital presence to get clients through the door By Michelle Huie In this digital age, you already know having a strong website is vital in keeping your clinic thriving with new business. Check! But what are the next steps? How does one transform a business website into a competitive storefront that continually brings new customers knocking on your virtual “door?” There are many tricks of the trade, but in building my own company, stylish compression wear brand VIM & VIGR, I found some strategies to be more effective than others. Below are six strategies that helped me take VIM & VIGR to more than 800 retail locations and sell a quarter of a million pairs of socks in three years.
EFFECTIVELY EXECUTE AND USE YOUR SOCIAL MEDIA Social media is no longer optional for online companies and clinics to grow a successful digital presence. Even more so, it is essential to participate on all major platforms, including Facebook, Twitter, Instagram and Pinterest, to maximize your reach of potential clients and patients. The key to being social is being authentic. Because you are in the health and wellness space, sharing ways your patients can maintain their health gives your brand more personality and positions your clinic as a thought leader in the space. The more sharable your posts, the better! If followers interact with your content, this increases the number of people who see your post; this in turn drives more “likes” and traffic to your pages, which ultimately brings more customers to your website. We prioritize VIM & VIGR’s social media presence and use these platforms to engage with our customers. But a word of caution: your focus on all platforms must be maintained on a regular basis to ensure public awareness of and involvement in the brand. If you let your social pages go quiet for too long, people may think your clinic has closed and opt for a competing business.
FOCUS ON WHAT WORKS BEST FOR YOUR COMPANY According to Entrepreneur.com, using Google Analytics or other platforms of analysis as a tool to determine what effectively measures the source and quantity of leads or sales is key to gaining a powerful digital presence. VIM & VIGR regularly examines Google Analytics to understand its most important distribution channels and uses this
information to budget for targeted advertising opportunities. However, when determining your own advertising plan, in general try following the 80/20 rule. If you can identify the top 20 percent of traffic sources that generate 80 percent of results and focus your spending on those sources, you will use your marketing funds more effectively, which will lead to more clients and higher revenues.
ALIGN MARKETING EFFORTS ACROSS ALL CHANNELS To avoid potential client confusion, your business must communicate a consistent message across all marketing channels. The message should be simple, meaningful, and genuinely embody the beliefs that represent what your company is about. VIM & VIGR uses multi-channel marketing to promote its products on all available dimensions to expand customer reach to its fullest potential. From a bird’s eye view this would look like actively engaging on all social media sites including Facebook, Instagram, Twitter and Pinterest, as well as intertwining execution across email campaigns and your website. It’s said that an individual must see an ad 30 times before they would be able to recall the brand. Because of this, VIM & VIGR maintains the same understandable wellness message across all platforms to ensure consumers always know what our brand stands for. Consistent messaging and alignment of interactions with consumers reinforces the brand’s credibility and raises brand awareness.
HAVE A BLOG PRESENCE According to the Huffington Post, “blogging is one of the most effective ways to improve the visibility of your brand online.” An important thing to note is that your blog should not be self-promotional. VIM & VIGR’s blog includes valuable material and exchange of information that educates the customer on compression socks but also provides tips for wellness that will benefit their day-to-day life. Regularly sharing blog content also improves your search engine rank, which establishes validity in your brand and increases reach – all important factors for establishing your business’s digital presence.
OPTIMIZE YOUR WEBSITE You must optimize your website to have superior performance on search engines. In
VEIN THERAPY NEWS < APRIL/MAY 2017
order to do this, one should include metatags, research keywords that are effective and compatible with your site and organically use them throughout your content, encourage other sites to link to your pages, and use alt tags to describe your images. This is key for a company to drive traffic to their site and convert visitors to customers. Optimizing your company’s website might be the easiest and most important ways to attract attention and build your clientele.
INVEST IN PRESS Part of earning a client’s trust is building your reputation as a credible and top-tier business. What better way of doing this than getting a nod from your local (and national) media! Having your business mentioned in a positive light by a well-respected media source positions your brand in a new light. Plus, the media recognition will drive extra traffic to your site, which only improves your website’s SEO and Google ranking and further improves your brand recognition. We try to capitalize on this as an additional SEO tool by linking VIM & VIGR’s media features back on our site. The internet is a big place, but it doesn’t have to be daunting. There are other strategies you can implement to help your business bring in more clients. For example, partnerships with like-minded brands that align with your industry and company values will spread your reach to people that may have never encountered your business previously. Remember that these kinds of campaigns can take some time to catch-on – it’s important to be patient and remember that results rarely happy overnight. If you’d like to start a conversation about working together, email VIM & VIGR at info@vimvigr,com. VT N
Working in the biotechnolog y and pharmaceutical industry for more than 14 years, Michelle Huie has dedicated her adult life to introducing innovative technology and products to people who need them most. In 2013, Huie founded VIM & VIGR: a high-quality compression legwear line with stylish designs to be worn all day. Today, she leads the VIM & VIGR team as they set out to bring the benefits of their products to people everywhere. To contact VIM & VIGR, email firstname.lastname@example.org.
THEPRACTICE GAME CHANGING
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team’s efforts, information is exchanged, care gaps are closed, and good health outcomes are delivered to your patients.
Go beyond traditional ways of reaching your patients by using new media, online
Whether your patients are using texts, mobile apps, social media or your portal, reaching them where they are and when it’s convenient for them is key to getting and keeping them engaged. Your education reaches them across all touchpoints and pushes them back to your website so your patients trust and value the information you provide. They have no reason to visit “Dr. Google.” In order for people to come to you for the patient education you provide, it has to meet a certain bar. Is it: • Evidence-based? The health information you provide must be accurate, up-to-date, and from a trusted source. • Unbiased? Your patient education needs to be impartial and free from corporate affiliation and influence. • Easy to understand? Ensure that you don’t miss opportunities to provide the education your patients seek. Use resources that are written in plain language so your patients will understand the first time they read it. • Consistent? If the education you provide is consistent, it reinforces your patients’ total experience, no matter who they talk to, what follow-up instructions they receive, or what information they get from your website.
PORTALS The important elements of a successful portal are the ability of patients to request a service, obtain information and submit information requested by their provider. And it’s essential that the portal be promoted and routinely used by the practice so patients know it’s there and see it being used. Portal usage is expected to grow significantly over the next few years, and it’s expected to remain a primary stage for patient engagement. Did you know that: • 50% of hospitals and 40% of U.S. physicians in ambulatory practice own some type of patient portal technology? • 43% of millennials access health care portals via a mobile device? • 56% of people ages 55 to 65 want to access online health information? • Among patients who don’t use online portals, 35% didn’t even know their provider offered one? • 64% of Americans own a smartphone, up from 35% in 2011? • 62% of all smartphone users have used their phone in the past year to look up information about a health-related condition? • 61% of consumer respondents are likely to trust information posted by providers via social media, and 41% are likely to share with providers? • 90% of 18- to 24-year-olds would engage in health activities and trust health information found via social media, and 56% of 45- to 64-yearolds would engage in health activities? Other important factors of portal adoption are provider acceptance and promotion, and ease of use.
TEXTING, SOCIAL MEDIA
As smartphone growth is increasing in the United States, so too is the growth in texting and social media as channels to promote health education, share information and deliver automated reminders. Many social media tools are available for providers and health systems. Tools such as social media platforms and blogs can be used for organizational promotion, patient education, professional networking and public health programs. Having an active social media presence allows practices to share information quickly in real-time on everything from news, medical tips, clinic capacity, local outbreaks, and technology. It lets the practice engage with the public and get patient reactions by following feedback on sites. The practice can then use the information to improve quality and foster relationships. Think of online communication as a way to educate and connect with your patients 24 hours a day with trusted, unbiased, consistent information that will bring them back to your practice time and again to create a loyal patient base.
Enhance your reach with automated, consistent health content and messaging
Automated content and messaging support the need to provide more patients with education and care between office visits. It means keeping in contact with and reaching more of your patients with basics such as appointment reminders and medicine schedules, and with more sophisticated education such as patient instructions, education about their conditions, event information, and remote monitoring. Its name may sound impersonal, but automated messaging is personal and relevant. It provides timely contact delivered to the device of each patient’s choosing. It enhances the patient experience away from the clinical setting. In a randomized study, subscribers who received a reminder were twice as likely to report that they were vaccinated against influenza. And 99 percent of them said they would recommend the service to a friend. In addition, subscribers reported that: The service gave them useful health information. • It helped initiate conversations with their health care provider. • It reminded them of important appointments and milestones. • It helped provide access to services and resources. The primary benefit of an automated messaging program is to increase patient engagement by providing more patients with the support they need to manage their health. The basics of a successful structure are: • Messaging programs that fit with your care needs and are easy to administer. • Tools to support patients’ pre- and post-appointment needs, providing patients with education ahead of their appointment that helps them be better prepared and then following up with prescription reminders so these tools can easily become part of your patient’s routine. • Online documentation of interactions with patients, so both you and your patient have well-documented health records. The benefits of an automated messaging system include: • You reach more of your patients outside the clinical setting at critical times – immediately before and after visits – enhancing their experience with information and education.
• You make relevant contact using patient education that fills information gaps with trusted, evidence-based information. • Your patients will get consistent education no matter where they touch your organization. Think of automated messaging as personal interactions with your staff that can be opened at any time that’s convenient for your patient and that arrive via whatever portal, smartphone or tablet that the patient wants. Because your patients can open the information when and where it’s convenient for them, they’re more likely to be engaged. VT N This article was written by Healthwise. For more information, see healthwise.org/ ACP MOBILIZES
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Sanjiv Lakhanpal and A.J. Riviezzo; AVF representatives Dr. Marc Passman, Dr. Fedor Lurie, Dr. Lowell Kabnick, and Dr. Glenn Jacobowitz; and SVM representatives Dr. Jerry Bartholomew and Dr. Raghu Kolluri. Also, from SVS representatives Dr. Sean Roddy and Dr. Matthew Sideman; SIR representatives Dr. Suresh Vedantham and Mr. Robert White; SCAI representatives Dr. Kenneth Rosenfield and Ms. Dawn Gray; VIVA Physicians representatives Dr. John Kaufman and Ms. Rebecca Hall; Alliance of Wound Care Stakeholders representatives Ms. Marcia Nusgart and Ms. Karen Ravitz; and industry representatives from AngioDynamics, Boston Scientific, BTG, Medtronic and Vascular Insights. And finally, I would be remiss without mentioning my ACP staffers who contributed greatly to this effort, including Michael Armitage, Nikki Mendez and Colleen Sengstock. This is truly a matter that has brought the entire venous and lymphatic community together, and the hope is that this monumental effort will yield positive results in opposition of the Novitas policy and serve as a model for increased collaboration activities in the future. Although the outcome of these efforts remains to be seen, this reinforces the need for all of us to consider the value of participating in a venous registry for our patients and for our survival as a clinical specialty. With registry data, we can demonstrate the value of vein care to the patients whom we provide care for. As of the writing of this article, the ACP PRO Venous Registry has nearly 19,000 unique patients, 40 percent of which are 65+ and 24 percent are in the near term Medicare population group of 55-64. As the data pool enlarges, many meaningful scientific questions can be answered about the contributions of venous care to both Medicare and pre-Medicare populations. VT N Keith A. Darby, CAE, CMA, CFE, is the interim executive director of the American College of Phlebology. He may be contacted via email at email@example.com and via Twitter @KeithDarbyCAE.
APRIL/MAY 2017 < VEIN THERAPY NEWS
THE RIGHT STUFF
Protect workers from injury with correct work conditions By Carolyn T. Coffin MPH, RDMS, RVT, RDCS All jobs require the “right stuff ” – the right tools, the right environment; but most of all, the right work postures. Worker injury can result from a number of unnatural work postures as much as it can result from slips and falls, lifting incorrectly or using tools inappropriately. The injury rates among sonography professionals, regardless of specialty, continue to be higher than other industries regardless of the many ergonomic features that have been incorporated into ultrasound systems and auxiliary exam room equipment. This indicates that worker postures are a significant part of the injury triangle – work tools, work environment and worker behaviors. These three are integrated within each work day and improving the ergonomics of one area only mitigates part of the injury risk. The “right stuff ” for a worker-friendly environment includes scheduling, review of exam protocols, support for work breaks and a mechanism for reporting injury. Patient scheduling should periodically be reviewed and should include input from the sonographers. The same type of exam should not be scheduled back to back. These exams use the same muscle groups and do not give the sonographers the opportunity to rest one set of muscles while using different ones. Work breaks should be enforced, and sonographers should be discouraged from using these breaks to do computer work or other tasks that mimic scanning work postures. Exam protocols should be reviewed on a regular basis and components that add no additional information and could potentially contribute to worker injury should be eliminated. We do not need to continue doing certain parts of an exam just because we always have done so in the past. Innovative ways for doing an exam should also be encouraged. An example is the venous reflux exam. This was initially performed with the patient standing, resulting in the sonographer sitting on the floor and reaching up to the ultrasound system. Having the patient stand up for this exam should only be done if venous reflux cannot be demonstrated using a 40-degree exam table tilt. Workers should feel comfortable reporting conditions that are potentially injury producing. There should also be a formal process for documenting injury and its progression. Workers should not be concerned
about negative repercussions when they sustain an injury. The “right stuff ” for work tools is exam room equipment that is flexible and has multiple adjustable features. Ultrasound systems should have a wide range of height adjustability. A very low minimum height is important for labs that do venous reflux exams. And, the maximum height should be enough to accommodate the majority of workers in the lab who may prefer to stand while scanning or when guiding interventional procedures. The control panel and monitor should be easy to move and should have a wide range of adjustability. The system should support an auxiliary monitor for those labs where interventional procedures are performed so that both the physician and the sonographer can have a monitor. The exam table should be electrically height adjustable, at the very minimum. Manually adjustable tables are not easy to adjust during the exam resulting in the sonographers leaving the table at a height that forces them into uncomfortable postures. Other features should be added to the table depending on the types of exams that are done in each lab. One of the more important pieces of equipment, both in the scanning room and in the computer work room, is the chair. Too often this is just any chair that is handy; however, there are a number of features of a chair that contribute to comfortable posture and good trunk and shoulder support. The exam room equipment is not the only part of this equation. How the room is set up is equally important. Often, ultrasound exam and procedure rooms are set up in whatever space is available. This results in very limited possibilities for arranging the equipment and often makes it impossible to move the equipment into different configurations. Large exam rooms are not necessary, but innovative equipment placement is. The best scheduling and injury reporting system and the best exam room equipment is only as good at the worker’s use of both. The “right stuff ” for worker behavior has many components. Workers’ must take responsibility for their health and safety and for their use of the exam room equipment. Sonographers must report any conditions that they feel contribute to injury and document any exams or other situations that increase injury risk. They must be willing to work with administration to find solutions while still supporting the need for timely patient care. Sonographers must be willing to learn the ergonomic features of all the exam
VEIN THERAPY NEWS < APRIL/MAY 2017
room equipment, as well as the computer workstations, and they must be aware of the work postures that they use throughout each exam. They should take advantage of the features of their equipment that can help them reduce arm abduction and reach. They should adjust the exam table height as necessary and have the patient move closer to them. Too often sonographers just do whatever is quick and easy without being aware of the cumulative effect of these activities. Similarly, in the computer work area, workers should use comfortable, supportive seating and adjust the monitor to a height that reduces neck
extension and the keyboard to minimize reach and arm elevation. Today’s healthcare facilities are faced with many challenges including standardizing exams, diagnostic confidence, reproducibility, timely patient care and work flow. Ergonomics can affect an entire organization, regardless of size, by enhancing the most important component of its business – the ability of workers to do their work. Ergonomics strives to fit the job to the worker rather than expecting the worker to
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SECONDLOOK UNETHICAL VEIN CARE continued from page 1
mandates. As an aside, under the 1949 Geneva Conventions, so called “collective punishment” is considered a war crime, but I digress. Medicaid and Medicare each dole out hundreds of billions of dollars per year. With large sums of money floating around complicated bureaucraties, healthcare is a tempting target for thieves, including physicians. While no one knows for sure how much of that currency is embezzled, the estimates are staggering. This led to the formation of a Medicare “strike force” in 2007. There are many horrific stories regarding unethical medical practice. Shocking news was reported a couple of years ago near my hometown in the Detroit area, when a physician was sentenced to 45 years in prison for providing medically unnecessary chemotherapy to patients. Toxic and potentially harmful infusions were provided to 553 individual patients, while approximately $34 million in fraudulent claims were submitted to Medicare and private insurance companies. Heading east, a cardiologist reportedly implanted nearly 600 potentially medically unnecessary stents from 2007 through mid-2009 at St. Joseph Medical Center in Towson, Md. The troubling story also detailed his lucrative relationship with the manufacturer of the stents and found that the questionable procedures cost the Medicare program $3.8 million.
ADDITIONAL PERSPECTIVE To gain additional perspective on this topic, I asked Thomas Siegel, MD; chief of surgery at Beaumont Dearborn; and local program director for the Wayne State University department of surgery, who spends countless hours doing quality assurance, to share his thoughts on unethical medical care. Dr. Siegel explained that in his field of practice, vascular surgery, the most prevalent kind of unethical care that he sees is relaxing or stretching indications for vascular procedures. In other words, inappropriate performance by interventionalists for more billable procedures. “According to the Society for Vascular Surgery the only indications for arterial interventions are: • Severe, debilitating claudication • Lifestyle-limiting claudication refractory to lifestyle modification and exercise regimen • Ischemia with rest pain • Ischemic non-healing lower-extremity ulcers When asked what was the specific worst instance of unethical medicine he has witnessed, Dr. Siegel’s answer should scare everyone: “I have cared for a patient who was able to walk more than a mile, who underwent laser atherectomy and subsequently required an above the knee amputation.”
DR. SIEGEL’S VIEWS Dr. Siegel shares his thoughts on ethical healthcare and insurance: “Practice surgery on the basis of scientific evidence, clinical indications, fiduciary responsibility and empathic regard for the genuine needs of patients, remains the best response to the forces that have buffeted medicine.”1 “Let not desire for wealth or benefit blind me from seeing the truth. Deem me worthy of seeing in the sufferer who seeks my advice a person neither rich nor poor. Friend or foe, good man or bad man. If doctors wiser than me seek to help me understand, grant me the desire to learn from them, for the knowledge of healing is boundless.”2
He goes on to suggest patients seek a second opinion before undergoing any invasive procedure. “There have always been unscrupulous practitioners, who will prey on the desperation of sick people,” Dr. Siegel said. ”This has led to quackery, nostrums of all kinds to hair restorers, tuberculosis, cancer and scrofula cures sold by snake oil salesmen such as Colonel Beriah Sanders from Mark Twain’s The Gilded Age ‘a visionary who sold The Infallible, Imperial, Oriental Optical Liniment, and Salvation for Sore Eyes – The Medical Wonder of the Age.’ “Unethical care has always been with us and unfortunately always will. When there is a complex array of specialists to care for innumerable diseases and arcane medicines, the patient must trust his physician to guide him through. “In the vast majority of cases, the patient’s trust is well placed. The patient is managed wisely and compassionately. A diagnosis is made, the risks, benefits and alternatives of treatment are discussed with the patient and a treatment plan is arrived at. While the outcome may not always be a good one, it is at least an ethical one and is within the bounds of medical science. This process is repeated countless times every day. “Healthcare insurance could provide a level of scrutiny but there is little incentive for them to do so. Healthcare insurance is big business without constraint and scant oversight itself. “There is no equivalent to the Hippocratic Oath in the healthcare insurance industry. “Each year premiums rise and coverage drops. New schemes that require thousands of dollars in copays and deductibles serve only to make healthcare unaffordable to the average working class family. As a consequence, they delay seeing the doctor. “I think that healthcare insurance is a fine idea in concept. “Share the Risk.” But just like the pharmaceutical companies, the medical device companies and the hospitals, there are no benchmarks ,no metrics, no accountability, and only the desire to make greater profits for the shareholders in the “for profits” and obscene salaries for the CEOs and administration in the “not for profits”… and greater bonuses for them all. “In the grand scheme of things, the honest physicians, nurses, and mid-levels account for only a small part of the healthcare dollar.”1, 2,3 Unethical care in the quest for more money is ubiquitous and has been seen in every field. Sometimes, a simple solution can curb this financial appetite. A great example of such a problem and solution is described by Harry Wasvary, MD and chief of Colon-Rectal Surgery at William Beaumont Hospital.
DR. WASVARY’S VIEW
“In the 1970s, advancements in technology allowed the development of a flexible colonoscope that was able to remove polyps present in the colon. This industry grew as it became apparent that the removal of these polyps was a mechanism to screen and prevent the development of colon and rectal cancers.
“Properly trained gastroenterologists and colon and rectal surgeons were excited to perform a screening procedure that was both diagnostic and therapeutic. Third-party payers became aware of these benefits, and in the year 2000 Medicare expanded its coverage to allow for a screening colonoscopy in average risk patients age 50 years and older. “Although an increase in colonoscopic screening had been on an upward trend since the 1980s; this trend increased significantly after the year 2000 as other insurer’s followed Medicare’s lead and third-party resources were now more available to perform colonoscopies. “Not surprisingly, as more resources became available, more physicians became interested in performing colonoscopies and endoscopy centers across the country were inundated with “endoscopists” who had little, or no, training in the procedure. “The term “scoping for dollars” was born and created a dilemma for properly trained physicians and hospital administrators as they debated how quality measures could be maintained in the face of this great influx of physicians now performing colonoscopies. “Quality measures that had been put into place previously: Polyp detection rate, complication rate and frequency of cecal intubation, were parameters that could be measured over time, but the need for a more immediate measure was required to combat the influx of lesser trained endoscopists. “Cecal intubation rates, the frequency that the scope properly advances to the most proximal part of the colon, is expected to be accomplished in more than 90 percent of cases, but the wave of self-proclaimed endoscopists created scenarios in which less than 70 percent of scopes were actually deemed to have completely evaluated the colon.”
PROBLEM SOLVED BY PHOTO?
“In an attempt to ‘weed out’ the lesser performers, endoscopy departments began to mandate photo-documentation of the cecum as proof that the physicians were properly completing the colonoscope. “This mandate had almost immediate results as it became apparent that these new endoscopists were unable to document compliance with this quality measure and they quickly removed themselves from the “scoping for dollars” craze that followed Medicare’s decision. “What worked for these individual endoscopy departments short term has also been successful long term and national tasks forces now expect cecal intubation rates with photodocumentation of the cecum to be greater than 90 percent.” It is interesting that photo-documentation, which is so much of a “gatekeeper” of society’s behavior in today’s world of smart phones, was already a mechanism for proper compliance in the world of endoscopy.”
ETHICS AND VEINS
A couple of recent patient visits give me reason for concern, and I believe this is only the tip of the iceberg. CASE 1 A 46-year-old healthy female complains of a few spider veins around her medial, distal left thigh. She denies all lower extremity symptoms. She denies pain, aching, swelling, heaviness, throbbing, night cramps and restless legs. Her past medical history is completely unremarkable and she is not taking a single medication! She went to a vein clinic where a bilateral lower extremity duplex “revealed four bad veins.” She was told she needed UNETHICAL VEIN CARE
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APRIL/MAY 2017 < VEIN THERAPY NEWS
The ethical dilemma of being FIRST By Harry Wasvary, MD For the greater part of the 20th Century, the pace of progress in surgery was dictated by science. Surgical dogma dictated that if a new technique was to be performed on a human being, that technique must first be proven worthy in a basic science or animal lab. Such diligence, however, cannot be said of the pace and process for which new technology has driven the surgical market in the past 30 years. In the 1980s, the concept of minimally invasive surgery was dominating the discussions of surgeons from all specialties. At that time, I was a young medical student cycling through the standard third-year rotations at the Detroit Medical Center. On the FIRST day of my surgical rotation, there was great excitement amongst the surgical staff as the FIRST laparoscopic gallbladder surgery was to be performed by one of the cutting edge surgeons at Harper Hospital. The operating room was truly a theatre as the room was filled with excited healthcare personnel eager to be part of this journey into a new world of minimally invasive surgery. This FIRST minimally invasive gallbladder surgery went smoothly; the patient had an uneventful postoperative course and the race to be a minimally invasive center was on! However, as healthcare institutions across the nation embraced this new wave of surgery, it became apparent that not all laparoscopic gallbladder surgeries were going as smoothly as the one I FIRST witnessed. In fact, it became apparent that the early experience of these FIRST time laparoscopic surgeons was anything but smooth, and the rate of complications was found to be two-fold greater than that of gallbladder surgeries being done by the standard open technique. So what happened? What had gone wrong as surgeons and hospital centers rushed to become the FIRST in their communities to perform surgery by the latest and greatest technical innovations? Where was the science? Where was the proof? What randomized trials had proven that this surge of surgery through minimally invasive techniques had any merit? This question might be answered in my FIRST experience as I witnessed my FIRST laparoscopic gallbladder surgery over 25 years ago. As I mentioned, the room was filled with numerous healthcare workers, attending surgeons, residents, nurses, surgical techs and other medical students such as UNETHICAL VEIN CARE
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to have these veins ablated on four separate days. “Please schedule on your way out of the office.” Maybe they didn’t say please? “Something seemed fishy and my gut told me to leave” she explained as she came to our vein clinic for a second opinion. She wanted peace of mind and didn’t like the idea of having a medical condition. We repeated an ultrasound, and as you might have already guessed, this study was unremarkable. She was relieved. CASE 2 A 43-year-old male with bilateral lower extremity varicose veins, swelling and skin changes (C2, C3, C4a) shares his story. “I was hobbling around my office after having a procedure done at another vein clinic. When a colleague
VEIN THERAPY NEWS < APRIL/MAY 2017
myself. What I failed to mention was the presence of a relative newcomer to the operating room at that time. In these FIRST experiences with minimally invasive procedures, the role of the surgical sales representative became much more prominent and necessary as new tools of the trade were being pushed upon the surgeons at a rapid pace. Due diligence through scientific trial and error, animal lab research and randomized trials was quickly being replaced by marketing and technology. Fast forward several years and I find myself facing the same dilemma as a young attending surgeon fresh out of my fellowship in Colon and Rectal Surgery. It is the turn of the century and minimally invasive surgery is now embraced at a much higher frequency and the indications for this approach are ever expanding. Many surgeons in southeast Michigan are racing to be the FIRST to perform laparoscopic colon surgery and to be the FIRST to remove cancers through these new mechanisms. Yet again, where is the science; where is the research, where are the prospective trials which are touting the benefits of this approach? Thankfully, my temptation to choose industry over science was made much easier when the American Society of Colon and Rectal Surgeons (ASCRS) placed a moratorium on laparoscopic colon cancer surgery until there was actual scientific evidence that this approach was comparable to the standard open colectomy. The trial that ensued took several years to complete and randomized patients with colon cancer to an open or laparoscopic approach. In May 2004, the principal investigator of this trial addresses the ASCRS at its annual meeting and reveals that both surgical methods yield similar results with regards to surgical and oncologic outcomes. At the completion of this presentation, the entire crowd of surgeons gave the principal investigator a standing ovation, not for the promising results, but for reasons of due diligence in which science had triumphed over industry. I am thankful to be part of a group that didn’t jump to be FIRST. During the moratorium, I directly and indirectly became aware of many laparoscopic procedures that went awry. In the quest to be FIRST, complications that were unique to this new approach began to show themselves at an alarming rate. Early on, without proper experience and without the support of scientific proof, minimally invasive techniques led to higher recurrence rates of cancer at the sites where the saw me, he asked what was wrong, and after I told him, he referred me to you.” I was shocked when he explained that his treating physician told him that only half of one of his veins would get treated initially. He would need to return a few days later to get the rest of his vein treated. The varicose veins would get treated at a later date. Unfortunately, patients without symptoms of venous insufficiency are getting told that they need a great deal of medical care. And to make matters worse, procedures are scheduled to maximize profit causing a major inconvenience to patients. We can all agree that separating a treatment to ablate half a vein on one day (Case 2) and the other half a different day is especially troubling. I wish I could think of a legitimate reason to do so. My only guess is that this was done to increase reimbursement. Data from Medicare fee-for-service (not including Medicare Advantage Plans) reveals a 6371 percent increase
laparoscopic instruments were being placed (a complication not necessarily seen by the standard open approach). Furthermore, even the instruments themselves became sources of concern as vascular and gastrointestinal injuries from the laparoscopic equipment created complex and even fatal complications. With time, many of these complications experienced in the early trials of minimally invasive procedures are reduced as surgeons’ progress beyond the initial learning curve. However, in the race to be FIRST, who will dictate this “learning curve”? Will it be determined by the sales representative who will promote the latest technical advances and remind you of the number of cases your competitors are accomplishing in their quest to be FIRST? Or will it be a planned, well-organized approach in which your progress will be determined by scientific evidence that proves, or disproves, the benefits and safety of a new approach? In the short-term future, the choice to patiently wait for scientific proof or aggressively pursue the latest surgical innovation will remain a dilemma. In 2017, I am constantly reminded of this dilemma as I wrestle with options to introduce the latest options of robotic surgery to my patient base. Surgical technology is expanding at an exponential rate and waiting for science to catch up could leave one at the back of the pack. So how can we best balance this temptation to be the FIRST provider of new surgical approaches, yet provide these services with the knowledge such services are beneficial? For myself, I am confident the lessons taught by the ASCRS can be universally applied and serve as an example that due diligence, patience and scientific support will bring the best outcomes and latest technology to our patients. VT N Harry Wasvary, MD, is a specialist in colon and rectal surgery. He is an Associate Professor at Oakland University William Beaumont School of Medicine, where he is also chief of Colon-Rectal Surgery (Royal Oak). He has been on staff at the Medical School for 20 years, 13 or which at Royal Oak. He is also Director of Beaumont’s Multidisplinary Colorectal Tumor Clinic. He is certified by the American Board of Surgery and the American Board of Colon and Rectal Surgery.
in the number of endovenous procedures from 2004 through 2013. I’m sure it has only escalated since then. I doubt that this surge in procedures can be explained by an increase in the prevalence of venous disease. Unfortunately when CMS notes significant uptick in what they are paying for, they often make sweeping changes that can adversely affect all physicians rather than punish the few.
CAN HEMORRHOID HISTORY PREDICT FUTURE OF VEINS?
It is said that history often repeats itself. Could this be the case with vein care? Today, vein clinics are popping up all over the place. While many of these facilities are providing much needed care, it appears that others are not. Specifically, some are in it for only the money.
UNETHICAL VEIN CARE
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SECONDLOOK Physician blasts Novitas LCD
Here’s why the TVS 1470 is Number One...
EDITOR’S NOTE: A Texas physician who practices within the J-H jurisdiction covered by the Novitas Inc. proposed draft Local Coverage Determination (LCD) regarding treatment of varicose veins of the lower extremities, responds to the proposal. See cover story, Page 1.
By Michael Bardwil There is a reason that Novitas is doing this. There are vein “mills” that average a ridiculously high 3.3 saphenous ablations on the Medicare patients they treat. I have treated veins since 1988 when I completed my surgery residency. I performed my first saphenous ablation in February 2003, and have been all in since 2004. I have as much to lose as anybody with this potential policy change. Yet I don’t know what we can offer Medicare to make it reasonable for them to change their mind. I don’t know how much of the healthcare budget went to treatment of veins and 2000 nor do I know the percentage of the budget which went to the treatment of veins in 2016, but I would bet a lot of money that the percentage of money has increased exponentially. Treatment of class 2 and class 3 veins is neither life nor limb threatening, and with the healthcare budget being scrutinized, it is hard to justify the amount of money spent on treatment of class 2 and class 3 vein disease, but even less justifiable is the treatment of patients with normal veins. In the past month I have seen cardiologists and pain management doctors masquerading as vein specialists, recommending saphenous ablations in patients, not only with normal saphenous veins but in patients with asymptomatic minor spider veins with whom, the venous duplex ultrasound exams was not even indicated. I will acknowledge that while the best vein specialists are vascular surgeons, not all surgeons are good at treating veins. But at least most surgeons learn during their surgical training that even low-risk procedures have risks for complications, and procedures should not be performed without the proper indications.
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PRODUCTNEWS Drug forecast, analysis to 2025 detailed in VTE response report The pharma response to Venous Thromboembolism (VTE) is covered in a new Research and Markets report titled “PharmaPoint: Venous Thromboembolism – Global Drug Forecast and Market Analysis to 2025.” VTEs often are preventable, with strategies that stop the development in people “at-risk.” Healthcare professionals discern risk by gathering information about a patient’s age, medical history, medications and lifestyle factors. Those at risk may take anti-clotting, blood-thinning medications or use mechanical devices such as compression stockings and a cuff. Some may also be instructed to move around or do foot/leg exercises as soon and as often as possible. Anyone who is inactive and sits for a long time, or smokes, is at risk. VTE includes deep vein thrombosis (DVT), when a blood clot forms in a deep vein, usually in the leg. And it includes pulmonary embolism (PE), when the clot breaks off and travels from the leg up to the lungs. DVT and PE are serious, life-threatening conditions that require immediate medical attention. Early diagnosis and treatment can often lead to recovery, but long-term complications may occur. Treatment typically includes blood thinning medication to break up clots and prevent new ones from forming. Options include: • Anticoagulants, including injectables such as heparin or low molecular weight heparin, or tablets such as apixaban, dabigatran, rivaroxaban, edoxaban and warfarin. • Equipment such as compression stockings and air compression cuffs and garments for the legs, calves, arms or chest that fill with compressed air and help increase blood flow. • Thrombolytic therapy, which includes drugs such as a tissue plasminogen activator (tPA) – a clot-dissolving enzyme. In rare cases, surgery may also be needed. It may involve placing a filter in the body’s largest vein to prevent blood clots from traveling to the lungs, removing a large blood clot from the vein or injecting clot-busting medicines. According to the new report, the Novel Oral Anticoagulants (NOACs) will see a significant increase in patient shares for the treatment of VTE and VTE primary prophylaxis against the established vitamin K antagonists and heparins. However, there are considerably high unmet needs within the indication. What are the main unmet needs in
this market? Will the drugs under development fulfil the unmet needs of the VTE market? The current late-stage VTE pipeline consists of betrixaban, in particular, which is vying for entry into the VTE market as the first NOAC approved for extended prophylaxis in acute medically ill patients – a significant unmet need in the VTE space. Xarelto is also contending for entry in this space through an additional label expansion for the established therapy. Will the late-stage drugs have a significant effect on the VTE market? Which of these drugs will have the highest peak sales at the highest CAGR, and why? There has been a significant increase in the VTE population, in terms of diagnosed incidence and recurrent attacks, as well as an increase in the prophylaxis population. How will epidemiological changes affect the growth of the future market? The scope of this study includes: • Overview of VTE, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines. • Annualized VTE therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for 10 years to 2025. • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the VTE therapeutics market. • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs. • Analysis of the current and future market competition in the global VTE therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications. Companies examined in this report include: Boehringer Ingelheim, Bayer, Janssen (Johnson & Johnson), Bristol-Myers Squibb, Pfizer, Daiichi-Sankyo and Portola Pharmaceuticals. VT N READ MORE: researchandmarkets.com/ research/l59mdh/pharmapoint
Report details venous leg ulcer The latest Pharmaceutical and Healthcare disease pipeline guide “Venous Leg Ulcers (Crural ulcer) – Pipeline Review, H1 2017,” provides an overview of the Venous Leg Ulcers (Crural ulcer) (Dermatology) pipeline landscape. Venous leg ulcers develop when persistently high blood pressure in the veins of the legs
(venous hypertension) causes damage to the skin, which eventually breaks down and forms an ulcer. Symptoms include swollen ankles filled with fluid that temporarily hold the imprint of finger when pressed (known as pitting edema), discoloration and darkening of skin around the ulcer (known as hemosiderosis), hardened skin around the ulcer, which may make leg feel hard and resemble the shape of an upsidedown champagne bottle (known as lipodermatosclerosis), and small, smooth areas of white skin, which may have tiny red spots (known as atrophie blanche). Venous Leg Ulcers (Crural ulcer, dermatology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from our proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. VT N READ MORE: researchandmarkets.com/ resea r c h / h zd f x7/venous _ leg _ ulcers
Penumbra shows growing suite of products at SIR ’17 Penumbra has a growing suite of thrombectomy and embolization products for use in a range of peripheral vascular conditions that they had on display at the Society of Interventional Radiology 2017 meeting in March: • The Indigo System is a next-generation continuous aspiration thrombectomy device designed for the removal of fresh, soft emboli and thrombi from the peripheral venous and arterial systems, and includes four catheter sizes (CAT 3, 5, 6 and 8). The aspiration lumen is paired with a proprietary continuous vacuum aspiration pump to evacuate clot. The Indigo System’s proprietary Separator technology enables unobstructed aspiration for the duration of the procedure. The Indigo System, received 510(k) clearance in May 2015 to remove clots from the peripheral venous system, and it is one of the newest interventional advancements designed specifically to help physicians remove DVTs. • Penumbra’s embolization platform includes RUBY Coil; POD e(Penumbra Occlusion Device), designed specifically to occlude peripheral vessels; and POD
Packing Coil, which is uniquely designed to pack very densely behind Ruby and POD to occlude arteries and veins throughout the peripheral vasculature, including aneurysms. • The LANTERN microcatheter is designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral vasculature. It is offered in a variety of lengths and tip shapes. VT N READ MORE: penumbrainc.com/
Teleflex launches TrapLiner Catheter Teleflex Inc., a global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and the U.S. commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex on Feb. 17. The device is offered in three different sizes: 6, 7, and 8 Fr. The TrapLiner Catheter is similar in design to Vascular Solutions’ popular GuideLiner Guide Extension Catheter, with the added feature of an integrated balloon for trapping a standard 0.014-inch guidewire within a guide catheter. The TrapLiner Catheter can be used as an alternative method to the trapping technique that requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position. The technique of guidewire trapping for catheter exchange is most commonly performed in complex interventional procedures. “The TrapLiner is a one-of-a-kind product that combines two devices we had previously deployed independently during challenging cases into a single tool that enables the most complicated interventional procedures to be done more efficiently,” said Dimitri Karmpaliotis, MD, PhD, and director of CTO, Complex and High-Risk Angioplasty at Columbia University Medical Center, who was the first to use the device in the United States. “The primary clinical use for the TrapLiner is during cases in which over-the-wire microcatheters are required to cross calcified lesions, navigate bifurcations, or cross tortuous anatomy,” Dr. Karmpaliotis said. “During these procedures, the TrapLiner not only provides added backup support and deepseating for the guide catheter, but also allows the operator to maintain guidewire positioning when exchanging the microcatheter. “The distinct two-in-one capability of this device is highly desirable, as it greatly enhances the efficiency of complex procedures.” VT N READ MORE: teleflex.com
APRIL/MAY 2017 < VEIN THERAPY NEWS
PRODUCTNEWS R&M adds PoCUS report of findings to its offerings Research and Markets has added the “Global Point-of-Care Ultrasound (PoCUS) Device Market Size, Share, Development, Growth and Demand Forecast to 2022” report to its offering. The global PoCUS device market is expected to grow at a CAGR of 6.9 percent through 2025 The increasing prevalence of chronic diseases, increasing awareness about benefits of portable ultrasound devices, increasing healthcare expenditure, and technological advancements are the key factors driving the growth of the global market. Technological advancements have led to miniaturization of ultrasound devices. The development of compact ultrasound devices has revolutionized the healthcare diagnosis practice. Manufacturers in the global PoCUS device market are focusing continually on workflow enhancements and improving diagnostic performance. Several manufacturers are investing huge capital on research and development for providing point of care through smart phones, by incorporating portable ultrasound devices into the standard of care and exploring pre-hospital (ambulatory care) market. Geographically, Europe was the largest PoCUS device market in 2015 and it is expected to grow at a considerable rate during the forecast period. The factors driving the PoCUS device market in the region are increasing compliance for portable ultrasound for point-of-care, high prevalence of chronic diseases, increasing healthcare expenditure and technological advancements. The PoCUS device market is expected to witness the fastest growth in Asia-Pacific, during the forecast period. The highest growth in the region is attributed to the improving healthcare infrastructure, increasing need for point of care, and strengthening of networks of international device manufacturers. Opportunities in the global pocus device market include: • Growing geriatric population. • Increasing prevalence of chronic diseases. • Technological advancement. • Increasing awareness about the benefits of portable ultrasound devices. • Increasing healthcare expenditure. Factors hindering growth of the market and its effect on market forecasts include a lack of skilled sonographers and stringent regulatory requirements. VT N READ MORE: researchandmarkets.com/ research/4pktn9/global
Only EHR interfaced with the American College of Phlebology Pro Venous Registrywhich automatically collects both physician and patient reported outcome data
Achieve Meaningful Use Stage 2– 2014 ONC Certified
Vein specific templates – Consults, Follow ups, Ablations, U/S, Phlebectomy, cosmetic procedures
iPad Clipboard Application & Patient Portal
Endovascular specific templates – DVT treatment, Iliac Stent placement, IVC Filter, Internal Iliac Embolization, Gonadal Vein Embolization
Ideal for Start-up clinics, help with Insurance credentialing & graduated scale billing pricing
PQRS and ICD-10 ready
Templates auto-calculate CEAP & VCSS
Nurses Notes for pre, intra and post op
Advanced Scheduling capabilities – Auto reminder calls
Before & After Leg Photographs – interfaced with Appworx
Structured Reporting Interfaces with Ultrasound Equipment
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VEIN THERAPY NEWS < APRIL/MAY 2017
A PRC Medical Company
ACP PRO Venous Registry collects data on 19,000 unique patients and counting
By Michael Armitage As patient and payer needs continue to change, verifiable data in clinical practice is more important than ever. Understanding the scope of venous disease, the most effective treatment options and how those options affect quality of life for patients, improves care and patients’ lives, as well as allowing for engagement with payers, policy-makers and the public. “There are tremendous pressures in our specialty – disease states that are unrecognized, patient outcomes are largely nonexistent, and declining reimbursement for procedures,” Marlin Schul, MD, said. “Additionally, the patient’s voice is critical. When captured, this allows us to identify both the quality of life and economic benefit as perceived by our patients.” Led by Dr. Schul and Yung Wei Chi, MD, the ACP PRO Venous Registry is the only dedicated venous research database populated with data from participating practice electronic medical records (EMR) systems.
While eliminating redundant manual entry, the registry also provides more than 600 data fields specific to deep and superficial venous disease. The registry represents the most comprehensive picture of vein care through the collection of both physician and patient reported data. As science advances, the system will grow without limitations, allowing an infinite number of new diagnoses, procedures and treatments to be added quickly and easily for future use. ACP PRO Venous Registry data provides investigators and practitioners valuable insight into diagnostic and treatment efficacy through: • Treatment outcome benchmarks, • Venous disease patient demographics, • Quality of Life (QoL) indicators based on treatment options, • Accurate and comprehensive vein care statistics, and • Commonalities in treatment protocols. The database now contains more than 19,000 unique patients and 77,000 patient records from 99 physicians in 90 locations. With data from Vein Clinics of America, and
discussions to add Centers for Vein Restoration (CVR) and Circulatory Centers, along with three certified EMR vendors – StreamlineMD, Aprima and Medstreaming – the data is available, which can be utilized to conduct meaningful, evidence-based research. Dr. Chi is the first to utilize the registry resources with a study entitled, “Health Related Quality of Life Questionnaire in Compression Therapy and Epidemiological Pattern of Registry Participants.” He presented his findings at the ACP Annual Congress this past November. The abstract has already been published in the online December 2016 issue of Phlebology. “If you are serious about veins and wish to continue to be reimbursed for your work, you should seriously consider registry participation that will allow you to not only easily capture your data, but will also allow patient involvement,” Dr. Schul said. For more about the ACP PRO Venous Registry, please see phlebology.org/registry. You can also view the registry dashboard at veinstats.org. VT N
APRIL/MAY 2017 < VEIN THERAPY NEWS
Call for Abstracts The 2017 Congress Program Planning Committee of the American College of Phlebology is seeking abstract submissions for consideration at the 31st Annual Congress, November 2-5, 2017 in Austin, Texas on the following topics:
SUPERFICIAL VENOUS INTERVENTION - Endovenous Ablation
SUPERFICIAL VENOUS INSUFFICIENCY
SUPERFICIAL VENOUS INTERVENTION - Sclerotherapy
DEEP VENOUS INSUFFICIENCY
SUPERFICIAL VENOUS INTERVENTION - Venotonic drugs
SUPERFICIAL VENOUS INTERVENTION - Miscellaneous
PELVIC CONGESTION SYNDROME
SCIENTIFIC REPORTING - ACP Pro-Vein Registry Reports
SCIENTIFIC REPORTING - Quality of Life Assessments
SCIENTIFIC REPORTING - Outcomes Reporting
SUPERFICIAL VENOUS INTERVENTION - Surgery
SCIENTIFIC REPORTING - Technological Advances
Deadline for Submission is June 14, 2017 Abstracts must be submitted online. For additional details and to submit online, please visit:
advancing vein care
www.phlebology.org | 510.346.6800
VEIN THERAPY NEWS < APRIL/MAY 2017
31 ANNUAL CONGRESS ST
REVOLUTIONARY INELASTIC WRAPS SIGVARIS launches wraps with unique compression measuring system SIGVARIS now offers three inelastic compression wraps that include a one-of-a-kind initial pressure measurement system. This new system not only allows clinicians to prescribe a compression level for their patients, but also, allow patients to easily set the correct initial compression level as 20-30mmHg, 30-40mmHg or 40-50mmHg when they put the garment on. “This product enhancement is going to change the market for inelastic wraps and finally give clinicians the confidence that patients will be able to accurately set their garment to the correct compression level at home,” said Scot Dubé, president and CEO for SIGVARIS North America. “This concept is truly revolutionary for inelastic compression wraps and is creating a new standard of care for patients who use inelastic compression wraps daily.” The new ACCUTAB system (with patent pending) works exclusively with COMPREFLEX(BK), COMPREFLEX LITE and COMPREFLEX NF (no-foot option) and now comes standard with these garments.
Color pressure ranges are clearly marked for ease of use and the tab can also be trimmed, so that patients can set the pressure in place by feel rather than sight, making it easy to use for patients who have a limited range of motion. Keith Hoffman, director of operations for inelastic compression for SIGVARIS North America, said most inelastic brands do not offer a System allows patients way to measure compression. to set correct correct “We spent a lot of time compression. working with patients and clinicians to ensure this will be the easiest, most accurate device for measuring initial
compression,” Hoffman said. “Accuracy is important for better clinical outcomes, and an easy patient experience means higher rates of compliance.” SIGVARIS North America is part of an internationally active medical device group headquartered in Winterthur, Switzerland, that focuses on the development, production and distribution of medical compression garments, including hosiery, socks and inelastic compression garments. With distribution in more than 70 countries on six continents, SIGVARIS is recognized as a global provider in compression therapy for the management of chronic venous disorders, lymphedema and wound care The 159-year-old company’s U.S. manufacturing plants are in Peachtree City, Ga., and Holland, Mich. To learn more about the Sigvaris complete line of compression products, including inelastic compression wraps for patients with wounds, severe edema and lymphedema, see sigvarisusa.com. VT N
Signia surgical stapler senses tissue thicknesses Medtronic’s newest addition to its growing minimallyinvasive surgery portfolio is the single-handed, powered Signia surgical stapler, which has the ability to sense human tissue thickness and automatically adjust stapling speed to achieve consistent staple lines. The Signia device achieves this through what Medtronic calls Adaptive Firing technology, which detects the variability of tissue and provides real-time feedback in the palm of the surgeon’s hand. For example, tissue is known to be thinnest at the top of the stomach and thickest at the bottom of the stomach near the small intestine. Signia’s sensors can detect more accurately the thickness of the tissue being worked. Medtronic Signia “When you clamp down on a surgical stapler tissue plain, in many cases you
are guesstimating the thickness of that tissue,” Chris Barry, Medtronic’s president of surgical innovations, said. When the surgeon grasps the tissue, an LED display window on the Signia device provides real-time audible and visual feedback, and “tells the surgeon whether the tissue is within the range” of the staples. Otherwise, the staples can be changed. The Signia device is designed for one-handed operation, and is completely powered. Dana Portenier, MD, FACS and co-program director of the Duke Minimally Invasive and Bariatric Fellowship division chief, and Duke Metabolic and Weight Loss Surgery Duke Regional Hospital chairman of surgery, praised the product. “In my experience to date, I believe the articulation, rotation and firing of the Signia system provides an important new option in the performance of minimally invasive surgical procedures,” Dr. Portenier said. “Its ability to provide the surgeon with helpful data and realtime response has the potential to contribute to more informed surgical decision-making.”
Signia is one of 15 new products that Medtronic’s Minimally Invasive Therapies Group (MITG, formerly Covidien) is launching during the second half of the company’s fiscal year, which ends in April. Medtronic CEO Omar Ishrak said last November that the roll-out will help MITG grow in the midsingle digits for the period. Initially, the company will introduce the Signia System in the United States, Western Europe and Japan, followed by additional markets worldwide during fiscal year 2018. Barry said the Signia system is a first-of-its-kind stapling system and represents the company’s commitment to pioneering intelligence-based minimally invasive surgical solutions. “Ultimately, healthcare should help patients get better, faster with less pain; MIS delivers on that commitment.” VT N
Venous blood collection tube industry compared to Chinese efforts “Global and Chinese Venous Blood Collection Tube Industry 2017-2022” gives an overview report of the global market of the venous blood collection tube industry and then an analysis of how the Chinese market is affecting it. The Research and Markets report” is a professional and in-depth study on the current state of the industry with a focus on the Chinese market. The report provides key statistics on the market status of the venous blood collection tube manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.
First, the report provides an overview of the industry, including its definition, applications and manufacturing technology. Then, the report explores the international and Chinese major industry players in detail. In this section, the report presents the company profile, product specifications, capacity, production value, and 2012-2017 market shares for each company. Through the statistical analysis, the report depicts the global and Chinese total market, including capacity, production, production value, cost/profit, supply/demand and Chinese import/export. The total market is further divided by company,
by country, and by application/type for the competitive landscape analysis. The report then estimates 2017-2022 market development trends of the venous blood collection tube industry. Analysis of upstream raw materials, downstream demand and current market dynamics is also carried out. In the end, the report makes some important proposals for a new project of the Venous Blood Collection Tube Industry before evaluating its feasibility. VT N READ MORE: researchandmarkets.com/ research/z4fnl3/global
APRIL/MAY 2017 < VEIN THERAPY NEWS
PRODUCTNEWS VasoCARE offers new technology VasoCARE LLC provides new device technology for treating and managing peripheral vascular conditions such as arterial foot ulcers and/or claudication limb pain.
DISUSE MUSCLE ATROPHY
It may be time to rethink how calf muscle pump dysfunction due to disuse muscle atrophy affects blood flow in the lower extremities and the healing of diabetic foot ulcers or reducing claudication limb pain. Physicians are frustrated with off-loading when treating diabetic foot ulcers since offloading devices fix the ankle at 90⁰ which leads to calf muscle pump dysfunction along with impacting the circulation in the lower limbs. Inactivity of the calf muscle pump results in a 47 percent decrease in venous outflow, 13 percent in heart rate and reduced arterial inflow to the legs.
Enhancing quality of home care with advanced technology to treat lymphedema, venous stasis ulcers, diabetic foot ulcers, and claudication limb pain.
The VeinOPlus Vascular device utilizes the latest in neuromuscular electrical stimulation to emit a specific electrical signal every second which recruits the calf muscle fibers. Each impulse causes the calf muscle to contract much like what happens during the act of walking. Studies show each impulse causes venous outflow to be increased 7 times, peripheral vascular resistance is lowered by 35%, and arterial inflow is increased 4 times. One hour of therapy is like the patients has taken 3,600 steps. Studies show two to three hours of daily therapy with the VeinOPlus Vascular device increases foot temperature 2⁰ or more, improves ankle/brachial index 5% or greater, and increases absolute walking distance in claudicants 90% which clearly confirms the increase in arterial inflow so needed in the healing of diabetic foot ulcers and reducing pain in claudicants. The VeinOPlus Vascular device therapy weighs 24 grams, battery powered, and the therapy is pain-free. Patients appreciate the portability and ease of use. The VeinOPlus Vascular device offers a new solution in treating arterial insufficiency. It’s about improving blood flow! Pocket size. Safe. Easy to use. No risk of ischemia. Positive results. VT N
Venous Treatment Product News Vein Therapy News is the quickest route to your targeted marketplace! Email your product news to Larry Storer at
Bio Compression Pneumatic Compression Device • Compresses lymphatic and venous fluid • Reduces painful swollen limbs • Increases range of motion & functionality • Accelerates healing venous leg ulcers • Simplicity of use…press one button • Positive outcomes are achieved
VeinOPlus Vascular Neuromuscular Device • Increases venous outflow 7 times • Increases arterial inflow 4 times • Accelerates healing 3 times • Increases foot temperature 2⁰ or higher • Improves ABIs 5% or more • Increases walking distance 90% or more
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email@example.com VEIN THERAPY NEWS < APRIL/MAY 2017
PRODUCTNEWS The generic component of the drug was approved in 1997, but the shares of the drug are declining due to intense competition from Xarelto and Pradaxa. Also, the endorsement of healthcare organizations to use heparin than the Vitamin K antagonists will hinder the growth prospects further. VT N
Compression therapy market drivers detailed
Technavio publishes new report on VTE marketplace details through 2021 According to the latest market study released by Technavio, the global venous thromboembolism therapeutics market is expected to grow at a CAGR of more than 6 percent from 2917-2021. This research report titled ‘Global Venous Thromboembolism (VTE) Therapeutics Market 2017-2021’ provides an in-depth analysis of the market in terms of revenue and emerging market trends. This report also includes an up to date analysis and forecasts for various market segments and all geographical regions. According to Sapna Jha, a lead analyst at Technavio for cardiovascular and metabolic disorders research, “The global VTE therapeutics market is expected to benefit from the growing incidence of VTE worldwide. According to the Centers for Disease Control, every year around 0.9 million individuals are affected by VTE in the United States, of which 60,000 to 100,000 individuals succumb to this illness. Further, the presence of high unmet medical needs is expected to fuel the market growth.” For a free sample report, see technavio.com/ request-a-sample?report=56858 The market research analysis categorizes the global VTE therapeutics market into four major segments based on drug class. They are: Factor Xa inhibitors, Direct thrombin inhibitors, Heparin and Vitamin K antagonists. Factor Xa inhibitors: The Factor Xa inhibitor drugs market is growing at a fast pace with a CAGR of more than 11%, owing to the approval of novel oral anticoagulants (NOACs) such as rivaroxaban (Xarelto), edoxaban (Savaysa), and apixiban (Eliquis). These direct oral Factor Xa inhibitor drugs show better safety and efficacy profiles when
compared to conventional drugs such as heparin. Xarelto occupies a major share of the market and is an important drug in the market. Eliquis and Xarelto are recommended as efficacious alternatives of warfarin or aspirin for anticoagulation and stroke prevention by the American Heart Association and the American Stroke Association. Direct thrombin inhibitors: The direct thrombin inhibitors market is growing at a moderate pace. This can be attributed to the NOAC, dabigratan (Pradaxa), which was approved in 2010. The approval of reversal agent, Praxbind, will further increase the adoption rates, thereby driving the market growth. Praxbind is indicated for individuals treated with Pradaxa when reversal of the anticoagulant effects of the drug is needed for emergency procedures or in life-threatening or uncontrolled bleeding. Heparin: The global heparin market for VTE is expected to grow at a low rate during the forecast period due to the loss of patent exclusivity and easy availability of generics. For instance, Lovenox is the leading product in the market. Other major products include Fragmin, Fraxiparine, and Innohep. All these products have lost their patents, and their generics are easily available in the market. Also, exploiting the novel therapeutic applications of hepacute coronary syndrome and macrovascular disease leading to thrombosis may influence the marin and the emergence of strategic alliances among vendors may help offset the market,” says Sapna. Vitamin K antagonists: The market for vitamin K antagonists is gradually declining, owing to the increased acceptability of NOACs in the market. Coumadin (warfarin sodium) is the single largest vitamin K antagonist used in the market.
Technavio analysts forecast the global compression therapy market will grow at a CAGR of close to 6 percent during the forecast period in a new report. The research study covers the present scenario and growth prospects of the global compression therapy market for 2017-2021. To calculate the market size, Technavio analysts consider revenue generated from sales of compression products, such as compression bandages, compression pumps, compression stockings and compression tapes. Compression pumps are used to provide intensive compression therapy. Compression pumps can be classified into two types, lymphedema pumps or DVT pumps. Lymphedema pumps and DVT pumps are unique in that they treat the diseases distinctly different. Lymphedema and DVT sleeves are
to be only used in conjunction with their corresponding pump to provide compression. Technavio healthcare and life sciences analysts highlight the following three factors that are contributing to the growth of the global compression therapy market: Increasing surgical procedures, growing adoption of sequential compression device systems and the presence of large patient pool with venous disorders and diabetes.
RISING SURGICAL PROCEDURES
The increasing surgical procedures such as hip and knee replacements increase the risk of DVT, thereby fueling the need for compression therapy systems. Surgeries often result in long periods of immobility, increasing the chances of developing DVT due to reduced blood flow. It is reported that more than a million Americans undergo joint replacement surgeries every year. Sapna Jha, a lead cardiovascular and metabolic disorders research analyst at Technavio, says, “After the treatment of varicose veins with micro phlebectomy, light-assisted stab phlebectomy, and radiofrequency ablations, physicians may prescribe compression stockings that can relieve pain and swelling,”
continued on page 37
APRIL/MAY 2017 < VEIN THERAPY NEWS
PRODUCTNEWS UNETHICAL VEIN CARE
continued from page 25
That’s similar to the situation that occurred in hemorrhoid care. According to Dr. Wasvary,“hemorrhoid clinics were making big bucks until changes were made in 2009. Before 2009, there were multiple codes by which one could bill for outpatient hemorrhoid procedures (rubber band ligations, sclerotherapy, infrared coagulation, etc.). Some of these codes had only a 10-day global period and thus the clinics could ask these patients back every 11 days for repeat procedures. After 2009, the newer codes greatly limited the option for a 10-day global period and substituted it for codes with 90-day global periods. Also in 2009, the reimbursement for ALL hemorrhoid procedures was greatly reduced and was another big blow to these clinics. These changes certainly reflect how one stroke of the pen can create drastic changes.” Could this will happen in our vein world? A recent development suggests this is a very real possibility.
Novitas Inc., a Medicare Administrative Contractor (MAC), proposed a draft Local Coverage Determination (LCD) regarding Treatment of Varicose Veins of the Lower Extremities (DL34924). This LCD would affect the 12 states within Centers for Medicare and Medicaid Services (CMS) jurisdiction J-H, which includes: Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania and Texas. If this LCD goes into effect, it will functionally remove medical insurance coverage for the majority of patients suffering from vein disorders since paragraph 1 indicates that only patients with advanced post inflammatory skin injury (C4b) or active ulcer (C6) will be eligible for coverage for ablation of the saphenous vein (if present), eliminating patients with symptomatic C2 (varicose veins), C3 (venous edema), C4a (pigmentation and active venous eczema) and C5 (healed venous leg ulcer) patients.
Most physicians are honorable people who try to help others and make a difference in our world. But there are good and bad individuals in every profession and medicine is no different.
Unfortunately, unethical medical practice is ubiquitous and I fear that it is on the rise our world of vein care. Are we approaching a tipping point? Will vein clinics follow the path of hemorrhoid clinics? Or, will we figure out a way to police ourselves and really effect change like we saw in the endoscopy world? Time will tell. VT N Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein, with five locations in Southeast Michigan. Dr. Miller has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.” His multi-site company has received numerous accolades including Coolest Place to Work by Crain’s Business Detroit, Novi Chamber of Commerce’s Customer Service Excellence Award and of Commerce’s Customer Service Excellence Award and several Corp! Michigan’s Economic Bright Spots Awards. See Resources for Unethical Vein Care on page 36.
Your Best Protection Against Penalties All physicians who applied for incentive money using VeinDraw have received full payments.
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To see how VeinDraw can work for you, schedule a live demo by calling 877.990.VEIN or visit our website atwww.veindraw.com www.VeinDraw.com This VeinDraw EMR is 2014 Edition compliant and has attained Complete Ambulatory EHR Certification from the ICSA Labs ONV Health IT Certification (ONC-HIT) Program. It has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services. Certificate number: 140319R00. Certified on November 3rd, 2014.
VEIN THERAPY NEWS < APRIL/MAY 2017
HEART OF HEALTHCARE
Providing and amplifying the voice of the patient By Jason Stanaland I’ve worked in healthcare IT for the majority of my career. My curiosity in tech was what brought me to the industry. My passion for helping others through health care is what has kept me here. I’ve always seen my role in providing communication technology tools for caregivers as having a direct effect on a patient’s life. Just like pulse oximeters and medications, the smartphone and its applications have become a critical part of the toolkit physicians rely on to save patients’ lives every day. I help deliver positive clinical outcomes. I’m part of the care team. This is central to what we all do in the healthcare industry, from clinical roles to administration to IT: We all work together to help patients. While in the hospital, the patient communicates with caregivers throughout the day, whether they are able to physically speak or not. When they are awake and in need of help, they may press a nurse call button. When they are unconscious and in need of help, machines may speak for them by alerting their caregivers of a change in vitals. Test results run in the lab deliver a message that everything is okay or further treatment is needed. Patients are speaking to providers constantly. It’s Health IT’s job to make sure the patient is heard, because what they have to say is often communicated through some form of technology. When patients enter the hospital in need of medical care, they are immediately connected to a network of technologies that begin “listening” to them. This technology can include heart monitors, infusion pumps, pulse oximeters, respirators and other medical monitoring devices. In many hospitals today, these technologies speak to caregivers by beeping loudly when the patient is in need of help. This is not the best way to communicate because it is ambiguous, limited in reach, and disruptive to the surrounding healing environment and clinical workflows. Nonetheless, this is the patient’s voice, asking for help. This is where my role on the care team (and the role of IT) comes in. It’s my job to help create stronger connections and better communication within hospitals through the use of technology. In many cases the most effective and efficient way to facilitate a connection to a caregiver is through a smartphone because they rely more and more on these devices to communicate and find information throughout the hospital. To ensure the patient’s voice is heard quickly and loudly, alerts must be prioritized over other information when arriving on a caregiver’s smartphone. To do this, we connect the machines that speak for patients to the caregiver, by way of the smartphone. When the patient’s ventilator goes into alarm, a result comes back from the lab or the patient presses the nurse call button, the software I help implement sends a priority notification to the appropriate on-duty caregiver’s smartphone. When the caregiver hears and sees this cry for help – presented to them accurately, appropriately and securely no matter where they are – they can react quickly to the patient’s need. We can make a difference by helping elevate the patient’s voice when clinically necessary. There are several ways this occurs.
PRIORITY RULES ENGINE
There are a lot of voices crying out for help in the hospital. It is vital for the technology that we implement to prioritize those
voices based on clinical severity in order to reduce clinician alarm fatigue. Spok’s clinical alerting technology can be programmed with a set of rules, so that the originating system (nurse call, lab information system, electronic health record, etc.) and the criticality of an alert can be filtered to trigger different workflows. For example, non-critical lab values may remain stored in the lab information system for caregivers to review before checking in with patients, while critical values may trigger a priority alert on a caregiver’s smartphone.
When a patient does call for help, directly or indirectly, there may be many caregivers around, but it is important that the right caregiver hears. An assigned nurse or hospitalist, an on-call specialist, or even a full care team may need to help the patient. We must use technology to leverage on-call schedules and notify the assigned caregivers of the service needed. That way when patients have those priority needs, the appropriate caregiver(s) can spring into action quickly without having to search around for others to help.
Many caregivers are often juggling multiple priorities and tasks at any given time. If a patient’s pulse oximeter goes into alarm and notifies the appropriate caregiver, but that individual is busy, technology must have the ability to escalate to a different person altogether based on on-call schedules and accurate contact information. This is particularly important in critical scenarios where calling around wastes valuable time. In some cases, the patient’s life may depend on quickly reaching an appropriate caregiver.
When patients ask for help via connected machines or critical test results, caregivers need to quickly understand who the patient is, their demographics and history, where they are located, and what medical event is taking place. As this typically represents highly sensitive patient information, alerts must be sent securely. The technology we implement to deliver critical messages to providers’ devices must be encrypted and HIPAA compliant. The voice of the patient is at the heart of health care. We must leverage processes, technology and people to listen and understand each patient’s needs. Clinical alerting and secure messaging solutions can help caregivers hear patients more clearly and reduce alarm fatigue. I see it almost every day. I can hear it in the halls of hospitals. Technologies and caregivers are listening to patients more and improving outcomes. VT N Jason Stanaland is a mobility solutions expert at Spok with 10 years’ experience in systems architecture design, enterprise mobility management, IT service management, project management, consulting services, and product marketing. This includes designing and supporting the critical messaging system at a large hospital system. While there he also implemented a secure messaging solution and successfully deployed it to more than 3,000 users. Connect with Stanaland on LinkedIn.
THE RIGHT STUFF
continued from page 23
fit into a static work environment. By reducing injuries, experienced workers can be retained and can perform at their best level. This affects the quality of patient care, productivity and profits. Just as in Tom Wolfe’s 1979 novel about military test pilots and those selected for Project Mercury, the “right stuff ” is not only the appropriate tools for the job, but the personal and professional skills to use those tools in the safest way and the willingness to adapt to new equipment features and change one’s work postures in order to reduce injury risks. VT N Carolyn T. Coffin, MPH, RDMS, RVT, RDCS is an ergonomics consultant for Sound Ergonomics LLC. She is currently the chair of the Department of Diagnostic Ultrasound at Seattle University. Her interest in occupational injuries among sonographers developed through her work with Joan Baker in the SDMS and was the focus of her research while working on a master’s degree in public health.
RESOURCES for Unethical Vein Care continued from page 35
James W. Jones, MD, PhD, MHA, Laurence B. McCullough, PhD and Bruce W. Richman, MA, Houston, “Show Me the Money: The Ethics of Physicians’ Income Tax JOURNAL OF VASCULAR SURGERY Vol. 42, No. 2 2004. 2 Moses Maimonides 12th century physician. 3 Enrico Ascher, MD, Presidential address Division of Vascular Surgery, Department of Surgery, Maimonides Medical Center, Brooklyn New York. • The United States Department of Justice Website JUSTICE NEWS Office of Public Affairs Friday, July 10, 2015. “Detroit Area Doctor Sentenced to 45 Years in Prison for Providing Medically Unnecessary Chemotherapy to Patients” • The Ethical Nag, Sept. 29, 2010, Carolyn Thomas, “Cardiologists Accused of Implanting Cardiac Stents That Weren’t Needed.” • United States Senate Committee on Finance Website: Dec. 6,2010, Baucus, Grassley Outline Millions of Wasted Taxpayer Dollars, Examine Reports Of Hundreds of Improper Cardiac Stent Implantations • Office of Inspector General, U.S. Department of Health & Human Services website. Medicare Fraud Strike Force • F1_1035_Crawford Forum-Vascular Surgery Procedures _ZWOLAK
APRIL/MAY 2017 < VEIN THERAPY NEWS
continued from page 34
said Sapna Jha, a lead cardiovascular and metabolic disorders research analyst at Technavio. “With an increase in the number of surgical procedures, the chances of developing thromboembolic events, requiring treatment using compression therapy systems are growing.”
GROWING ADOPTION OF COMPRESSION DEVICES The emergence of sequential compression therapy systems is expected to have a positive impact on the market, owing to its use in several applications. Sequential calf compression and graduated compression
stockings are increasingly being used for prophylaxis in neurosurgery for the prevention of PE and DVT. Further, intraoperative sequential compression device systems are recommended during prolonged laparoscopic surgery to counter altered venous blood return from the lower extremities and consequent cardiac depression caused by pneumoperitoneum. “With sequential compressions, such as the recovery edge therapy, each cycle continuously offloads the venous system during a 30-40 seconds’ sequence, thereby moving a substantial amount of blood and waste products,” Sapna said.
LARGE NUMBER WITH VENOUS DISORDERS
According to the CDC 2016 survey, more than 29 million individuals in the United
States are living with diabetes and 86 million individuals with pre-diabetes. The increasing incidence of diabetes increases the internal risk factors such as swelling of legs, ankles and feet, which will lead to venous disorders. Such rising incidence rates of diabetes and other related chronic diseases, in turn, increases the patient pool, which drives the compression therapy market growth. The report also details the top vendors in the field as Sigvaris, Medtronic, Getinge Group, BSN Medical and 3M. VT N Request a free sample report: technavio.com/request-asample?report=55951
Visit us online at VEINTHERAPYNEWS.com
Thromboembolism drugs analyzed Research and Markets has added “Venous Thromboembolism – Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2017” drug pipeline marketing report to its offering. The report provides the historical and forecasted sales of the drugs till 2018. The report provides comprehensive insights about the marketed drugs, drug sales, Phase III pipeline drugs and their API Manufacturers across the globe. A key objective of the venous thromboembolism report is to understand the market and pipeline status of the drugs around venous thromboembolism. VT N
VEIN THERAPY NEWS < APRIL/MAY 2017
PRODUCTNEWS Vevo LAZR-X offers ultra high frequency US for research
FUJIFILM VisualSonics Inc., a provider of ultra high frequency ultrasound and photoacoustic imaging systems and subsidiary of FUJIFILM SonoSite Inc., have announced the launch of its new Vevo LAZR-X, the world’s only customizable imaging platform combining ultra high frequency ultrasound and photoacoustics for animal research applications. Featuring superior image resolution – down to 30 microns – the Vevo LAZR-X was designed for a variety of translational research applications. “Fujifilm VisualSonics is proud to debut another industry-first and a powerful innovation for today’s busy researchers,” said Diku Mandavia, MD, FACEP, FRCPC, chief medical officer and senior vice president, FUJIFILM SonoSite Inc. and FUJIFILM Medical Systems U.S.A. Inc. “Our trusted Vevo technology is already used in hundreds of research laboratories. The
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new Vevo LAZR-X takes it to the next level, providing the ultimate preclinical imaging experience through a dual tool comprised of state-of-the-art ultra high frequency ultrasound and advanced photoacoustic technology.” Offering a fusion of anatomical, functional and molecular data, Vevo LAZR-X was designed for non-invasive, real-time, longitudinal studies. The all-in-one imaging platform puts more data at the users’ fingertips and is equipped with an array of software applications that allow researchers to conduct in-depth analysis and rapid quantification to advance research and get published faster. A portable, customizable system, Vevo LAZR-X pairs Fujifilm VisualSonics’ Vevo 3100 ultrasound system, which provides unparalleled resolution, with the compact LAZR-X cart featuring advanced laser technology for fast, sensitive acquisition along with dual wavelength ranges including signal (680-970nm) and idler (1200-2000nm). High-resolution MX linear array transducers can be paired with interchangeable, highefficiency optical fibers – giving researchers the ability to customize depth, sensitivity and resolution for specific imaging needs. Other features include streamlined data management, an intuitive touchscreen interface, ergonomically-designed transducers, and a unique open imaging environment that allows the researcher to access and manipulate the subject animal during the scanning process. Andrew Needles, director of marketing and product management, FUJIFILM VisualSonics, said that at Fujifilm VisualSonics the purpose is to boldly innovate new technologies that help scientists and researchers advance human health. “Our new Vevo LAZR-X platform is a great example of this continual innovation,” Needles said. “It is designed with flexibility in mind, allowing for application-specific imaging to collect robust data for exceptional translational research.” VT N READ MORE: visualsonics.com
Longer-lasting Juvéderm Vollure XC gets FDA OK The U.S. Food and Drug Administration (FDA) has approved Juvéderm Vollure XC (Allergan) for injection into facial tissue to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults older than 21 years, the company announced. In the U.S pivotal clinical trial, 59 percent of patients saw improvement in moderate to severe nasolabial folds for up to 18 months, with 82 percent of patients saying they were very satisfied at 6 months and 68 percent at 18 months, the company stated in a news release.
FDA clears two new dermal fillers for laugh lines. “What’s exciting about Juvéderm Vollure XC is that it was shown to last up to 18 months from the initial or touch-up injection in a majority of subjects, which is the longest lasting result shown in a clinical study in the nasolabial folds,” Joely Kaufman, MD, a board-certified dermatologist and clinical trial investigator from Coral Gables, Fla., said. Juvéderm Vollure XC is formulated with proprietary Vycross technology, which blends different molecular weights of hyaluronic acid, contributing to the gel’s duration, according to the company. The most common side effects seen in the clinical study were temporary injection site responses, such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching. Most of these side effects resolved within a week. Juvéderm Vollure XC will be available in the United States in April. The product was first approved in Europe as Juvéderm Volift in 2013. VT N READ MORE: Juvederm.com
SafeCT-29 meets FDA’s XR-29 CT compliance rule It’s 2017. Are you XR-29 compliant? As of Jan. 1, the penalty for XR-29 non-compliant CT scans for Medicaid/Medicare patients has tripled to 15 percent. Medic Vision has a solution that does not require replacing non-compliant scanners. SafeCT-29 is a FDA-cleared third-party solution available to meet XR-29 compliance for just a fraction of the cost of a new scanner. The SafeCT-29 is the only FDA-cleared third-party XR-29 solution; the only thirdparty XR-29 solution that is endorsed by CT OEMs; supports all CT and PET/CT scanners; and does not interfere or interrupt the scanner’s design and operation. VT N READ MORE: medicvision.com/usa/
APRIL/MAY 2017 < VEIN THERAPY NEWS
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