INSIDE Akesys touts its PRAVA scaffold AVF registering for 29th meeting LimFlow gets CE for end-stage CLI Congress gives Obama 21st Century Cures Act
DECEMBER 2016/JANUARY 2017 Vol. 10 No. 1 VEINTHERAPYNEWS.COM
12 14 26 30
An ACP recognized resource for news and information for and about the phlebology community
New CPT codes simplify billing for MOCA technique By Larry Storer While 2017 will bring some unknowns to everyone in healthcare with the election of a new president, beginning Jan. 1, 2017, it will actually be easier for physicians to get reimbursed when using the non thermal, non tumescent technique mechanical occlusion chemically assisted (MOCA) for treating incompetent veins. Two new Current Procedural Terminology (CPT) Category 1 codes – CPT 36473 and CPT 36474 – have been finalized and published by the Centers for Medicare and Medicaid Services (CMS) effective Jan. 1 for the technique of MOCA using ClariVein. The new codes describe ablation of the incompetent veins in the lower extremities using MOCA as the technique. It’s not that ClariVein is a brand new device. Even without its own CPT code,
Steve Elias, MD, FACS, FACPh
Adi Renbaum, MBA
physicians have performed more than 85,000 procedures with it since Steve Elias, MD, FACS, FACPh, completed the first in man clinical trial of ClariVein in late 2009.
valuable clinical time jumping through hoops to secure reimbursement.
It’s just that if physicians believed it to be the best tool for vein ablation for a particular patient, they had to bill it through a non-specific billing code and then spend
The new codes are important because they will allow automated claims adjudication, substantially simplifying and allowing consistent and predictable reimbursement policies for physicians, Medicare and commercial payers.
It is expected that after Jan. 1 the use of non-specific billing codes, such as CPT 37799 (Unlisted Vascular Procedure), and notations in the (paper) CMS-1500 claim form’s Box 19 for local use (and electronic equivalent), will no longer be required for MOCA, thus making it more accessible for doctors and patients. Adi Renbaum, principal and owner of ANR Consulting and a seasoned advisor who has worked with specialty medical societies and physicians to overcome payment barriers, said the two new codes will eliminate a significant reimbursement obstacle for physicians (not being able to bill for what may the best tool to treat a specific vein in a particular situation). There is a primary code – CPT 36473 – which can be billed by the physician when NEW CPT CODES continued on page 24
Pharmacist takes issue with webinar content bias By Michael Haulsee, PharmD
that it was going to be a one-sided presentation rather than a well-balanced overview of sclerosants and compounding pharmacies.
I recently attended a webinar presented by Dr. Nick Morrison in association with the American College of Phlebology titled "Compounded Sclerosants." As a pharmacist of 30 years, 19 of which I have owned and operated a compounding pharmacy, I was looking forward to this presentation from a well-respected phlebologist. However, very soon into the webinar, I realized
In my opinion, in order to effectively critique or criticize a subject in a public forum, one must be well-versed in all aspects of the argument at hand. Dr. Morrison admitted he knew nothing about USP 797, the rules and regulations
by which sterile compounding pharmacies work and are inspected. USP 797 is very stringent in reference to the environment sterile preparations are made, the training of the staff, testing of the final product and record keeping of the same. Adhering to USP 797, a pharmacy, when dispensing a COMPOUNDING continued on page 22
7HOH³H[DFTXLULQJ9DVFXODU6ROXWLRQV Teleflex Inc., a company that makes devices used in surgery, cardiac, respiratory and emergency care, is acquiring Vascular Solutions for about $1 billion. The deal is expected to close in the first half of 2017 and will add to Teleflex's adjusted earnings in 2017. Teleflex's offer of $56 per Vascular share in cash represents a premium of 1.6 percent to the stock's close on Dec. 1. The sale comes about 10 months after Vascular Solutions and its founder CEO Howard Root were found not guilty in a
criminal prosecution related to alleged "off-label" promotion of its varicose veins treatment, Vari-Lase Short Kit. Shares of Vascular Solution, which makes devices for minimally invasive coronary and vascular procedures, have nearly doubled since Root was exonerated in February. "Following the jury verdict in February ... I am not willing to assume much longer the personal risk associated with being the CEO VASCULAR SOLUTIONS continued on page 13
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VEIN THERAPY NEWS DECEMBER 2016/JANUARY 2017
New CPT Codes will ease billing
Beginning Jan. 1, 2017, it will be easier for physicians to get reimbursed when using the non thermal, non tumescent technique mechanical occlusion chemically assisted (MOCA) for treating incompetent veins.
Trump’s healthcare duo
President-elect Donald Trump said he will nominate U.S. Rep. Tom Price (R-Ga.), MD and chairman of the House Budget Committee, to lead the Department of Health and Human Services. In addition, Seema Verma, founder and CEO of the SVC Inc., has been selected to serve as administrator of the Centers for Medicare & Medicaid Services. Trump called the pair his healthcare “dream team.”
THE PRACTICE 18 Staying engaged with patient Patients rate the care they received lower when doctors looked at a computer screen a lot during examinations. Technology can streamline clinical workflows and improve care team communication. However, it has also inhibited the human side of medicine.
18 A bill you can understand HHS has announced the winners of its "A Bill You Can Understand" challenge, a design and innovation challenge to solicit new approaches and draw national attention to a common complaint with the healthcare system: that medical billing is a source of confusion for patients and families.
SECOND LOOK 1
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Vascular Solutions acquired
Teleflex Inc. is acquiring Vascular Solutions for about $1 billion. The deal is expected to close in the first half of 2017. Teleflex's offer of $56 per Vascular share in cash represents a premium of 1.6 percent to the stock's close on Dec. 1.
Compounding info challenged
A pharmacist took exception with the presenter and his content in an Oct. 12 ACP Webinar presented by Nick Morrison, MD. The pharmacist said the information was incomplete, outdated and biased.
20 Solving the ergonomics puzzle Technological advances have resulted in vascular ultrasound labs becoming more efficient and productive; but they have added to the risk for worker pain and injury. High rates of work-related musculoskeletal disorders among sonography practitioners are creating concern over patient care and staffing.
ACP UPDATE 28 30 years of venous education The American College of Phlebology celebrated three decades at the forefront of venous related education with the recently held Annual Congress, Nov. 3-6, 2016, at the Anaheim Marriott in Anaheim, Calif. The meeting remains the largest of its kind in the nation, drawing nearly 1,200 total attendees, including registrants, more than 100 faculty and 67 exhibiting organizations.
VTNREPORT AMERICAN VEIN NOMINATED FOR 2016 COLORADO GROWTH AWARD American Vein & Vascular Institute, a network of clinics specializing in vein and arterial disease, has been nominated for the 2016 Fastest Growing Company award, sponsored by the Colorado Springs Business Journal. This award honors and shines a light on Colorado Springs' fastest growing businesses and their local entrepreneurial success stories, according to Erin Gibbs, owner and CEO. Awards are given based on growth within the past three years, revenue size and other criteria. According to the awards committee, the 16 nominees contributed $95 million in revenue – generated in the past year alone – and created 600 new jobs. In 2016, amongst many growth accomplishments, American Vein & Vascular Institute opened its second clinic in Pueblo, Colo. This location is the first of its kind in Southern Colorado, offering an office-based endovascular center with diagnosis and treatment of patients with peripheral artery disease, chronic venous insufficiency and venous thromboembolism. Founded Jan. 1, 2010, American Vein & Vascular Institute has expanded to eight clinics plus a practice management headquarters in Colorado Springs. Seven clinics are located in Colorado and the remaining clinic is located in Texas. Erin Gibbs leads the practice management team that serves the clinics, all of which are owned and operated by founder and CMO, Gordon Gibbs, Md.
ABBOTT, ST. JUDE TO DIVEST VASCULAR CLOSURE, ELECTROPHYSIOLOGY UNITS TO KEEP MERGER ON TRACT Abbott and St. Jude Medical have agreed to sell off portions of their vascular and electrophysiology units, worth about $1.12 billion, to Terumo. The transaction is subject to the completion of the Abbott-St. Jude deal. The all-cash divestiture will see St. Jude offloading its Angio-Seal and Femoseal vascular closure products and Abbott cutting loose its Vado Steerable Sheath, according to a release. Abbott will get to hold on to its stable of vascular closure devices, such as the Perclose ProGlide Suture-Mediated Closure System and the StarClose SE Vascular Closure System. The transaction is under review by antitrust authorities. The deal comes as St. Jude sets up a new cybersecurity medical advisory board after a battery failure issue with some of its cardiac rhythm management devices cropped up in mid-October. The company warned of a possible problem with the lithium-based battery used in some of its implantable cardioverter defibrillators and CRT-D devices manufactured before May 23, 2015, and recommended that patients contact their physician immediately.
ANGIODYNAMICS RAISING 40M IN OFFERING AngioDynamics has priced a secondary offering, saying it plans to repurchase $8 million in shares itself from the round. The Albany, N.Y.-based company said the round should bring in a total of $40 million through the sale of 2.5 million shares at $16 per share, all offered by selling stockholders. AngioDynamics said it plans to repurchase a total of 500,000 shares to buy back an $8 million stake. All net proceeds of the round will go to the selling stockholders, the company said. Barclays Capital Inc. will act as the sole underwriter for the offering. In October, AngioDynamics reported its 1st quarter results for fiscal 2017, posting a 5 percent top-line gain and a swing to black ink. The company reported profits of $1.3 million, or 4 cents per share, on sales of $88.1 million for the three months ended Aug. 31. That amounts to a 5.2 percent top-line gain and a turnaround from losses of -$775,000 during the same period last year. Adjusted to exclude one-time items, profits were $6.4 million and earnings per share were 17 cents, up from an adjusted $4 million in sales and 11 cents in earnings per share.
BOSTON SCIENTIFIC HIRES CARDIOLOGIST IAN MEREDITH AS CHIEF MEDICAL OFFICER Boston Scientific hired Ian Meredith, MD, PhD, as executive vice president and global chief medical officer. Dr. Meredith, a cardiologist, will begin his duties in January 2017 and succeed Keith Dawkins, MD, who has been the company’s chief medical officer since January 2012. Boston Scientific announced the moves in an Oct. 10 news release. He is a professor at Australia's Monash University, director of MonashHeart and Monash Health and executive director of the Monash cardiovascular research center in Melbourne,
Australia. He has performed more than 10,000 invasive cardiac and coronary procedures, according to a news release. Meredith has also been chief or principal investigator on 30 international, multicenter trials, including the Boston Scientific Lotus Valve Reprise research program.
MEDTRONIC IN DEAL TO HELP RUN LABS IN CLEVELAND MEDICAL CENTER Medtronic has entered into a deal to operate the heart-catheterization and electrophysiology labs at University Hospitals Cleveland Medical Center. Cath labs and EP labs are specialty centers inside larger hospitals where the kinds of cardiovascular products Medtronic sells are often used, including higher-margin stents and foldable aortic heart valves, and a wide array of lower-tech hospital supplies. “The benefits remain to be seen, but we believe them to be an improvement in efficiency, labor management, supply chain management, [patient] throughput, scheduling – all the operating functions of the clinical unit,” said Dr. Jeffrey Peters, chief operating officer of UH Cleveland Medical Center. A spokeswoman said the hospital has 1,032 beds. Peters said as many as 10 Medtronic employees will work at UH Cleveland Medical Center, performing nonclinical work.
SIEMENS SPINNING OFF HEALTHINEERS Siemens is planning to spin off its Siemens Healthineers business as an independent publicly traded company. The spinoff will give Healthineers even more focus and flexibility in pursuing its growth strategy, said Siemens President and CEO Joe Kaeser. He said the move was part of the company's Vision 2020 plan, a restructuring initiative launched in May 2014 to streamline the company and make it more efficient. As part of the plan, Siemens jettisoned a number of businesses, such as hearing aids and lighting. With respect to healthcare, the Vision 2020 plan moved the business into a separately managed unit, while the core of Siemens retained its focus on the "electrification, automation, and digitalization" fields, the company said then. Under the latest plan, Siemens will list Siemens Healthineers as a publicly traded company. The timing of the listing will depend on various factors such as the stock market environment. Executives are portraying the move as a major step forward in the business' growth strategy.
HEALTH AFFAIRS BLOG SAYS NURSE SHORTAGE BEGINNING TO SLOW Edward Salsberg, a healthcare workforce researcher and health services research professor at George Washington University, writes in a Health Affairs blog that the number of newly educated registered nurse appears to be leveling off compared to several years of history growth. However, the number of new diploma-prepared nurses continued to decline, according to the blog. He writes that progress in growing the number of nurses varies across communities, and some may see a surplus of nurses while others will continue to see a shortage. “One implication is that efforts to spur future growth of the pipeline should be targeted to specific communities, rather than across all communities,” Salsberg wrote.
BIO-RESORT TRIAL SHOWS GOOD RESULTS FOR MEDTRONIC DP-DES Medtronic is boasting positive results from a clinical trial of one of its drug-eluting stents, a boon for the company as it competes in a crowded market.The data from the independent BIORESORT study showed that the company’s Resolute Integrity drug-eluting stent (DP-DES) performed as well as a biodegradable polymer stent in treating patients with coronary artery disease. Medtronic’s Resolute stent helped cut down on serious cardiovascular incidents such as target vessel failure and stent thrombosis over one year. “As in our previous randomized study-the DUTCH PEERS trial--patients treated with the Resolute Integrity stent showed low and favorable one-year clinical event rates,” Clemens von Birgelen, lead investigator on the trial, said. “The stent was an excellent challenge for the two novel very-thin strut biodegradable polymer drug eluting stents to compare with, and the results showed no significant difference in the 12-month incidence of the composite primary endpoint.” Medtronic is counting on long-term study results to deliver. The Dublin-based company has already shown that its stent helps reduce stent thrombosis in some patients during a five-year period. But it’s still working on developing the device’s safety profile compared to a biodegradable stent. VT N
DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
APPROVED BY FDA • 87% PATIENT SATISFACTION VS. 64% WITH STS*
Her legs aren’t the only place where the results will show. You may also see it in her expression.
Not an actual patient
In a clinical trial, 95% of patients treated with Asclera® (polidocanol) Injection for spider and reticular veins showed “good improvement” or “complete treatment success,” with a patient satisfaction rating significantly higher than STS (87% vs. 64%).*
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.
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 thrombosis.
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. © 2016 AngioDynamics, Inc. ANGAD 371 US Rev 1 11/16
DECEMBER 2016/JANUARY 2017
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HEALTHCARE ‘DREAM TEAM’ 7UXPSSLFNVSK\VLFLDQDQG0HGLFDUHH[SHUWWRRYHUKDXO2EDPDFDUH degrees from the University of Michigan, and completed his U.S. Rep. Tom Price (R-Georgia), MD and chairman of the Orthopedic Surgery residency at Emory University House Budget Committee, has been named as President-elect If confirmed, Dr. Price would be the first physician to Donald Trump’s pick to lead the Department of Health and lead HHS since Dr. Louis Sullivan in the George H.W. Bush Human Services. administration, 1989-1993. Sullivan also came to Washington In addition, Seema Verma, founder and CEO of the SVC from the Atlanta area. Inc., has been selected to serve as administrator of the Centers for Medicare & Medicaid Services. Dr. Price, an orthopedic surgeon from the 6th Congressional district outside Atlanta, has been one of the most vocal critics in Congress of the Affordable Care Act (ACA). He has long been a leader in Republican opposition to the ACA and worked on several comprehensive bills to replace it. Dr. Price and two other physicians wrote an op-ed in the JAMA Forum on the ACA in October 2016. “Ostensibly, the ACA’s primary intent was to expand access to underserved populations, but simply having an insurance card does not ensure that a patient has access to quality, affordable U.S. Rep. Tom Price, MD Seema Verma health care. Unfortunately, the all-out push to ensure access to health insurance is having two serious adverse effects: it’s making premiums unaffordable for middle-class individuals who are ineligible SEEMA VERMA for subsidies and it’s increasing out-of-pocket costs, deductibles If confirmed, Verma would be the second Indian-American and co-payments.” woman nominated to a top post in his administration. Her Dr. Price has promoted his own bill – Empowering Patients nomination came just days after Indian-American Nikki Haley First Act – since 2009, the year before Obamacare passed. He was named as U.S. envoy to the United Nations by Trump. has reintroduced the bill in subsequent years. In its latest form, Trump said Verma is his choice for CMS administrator the Empowering Patients First Act would allow refundable, because she has "decades of experience advising on Medicare age-adjusted tax credits with amounts tied to average insurance and Medicaid policy and helping states navigate our for people who buy insurance on the individual market and complicated systems." don’t have access to a government or employer plan. Under Dr. A leading expert in the country on Medicare and Medicaid, Price’s plan, for instance, people between 18 and 35 years of age Trump said Verma “has helping states navigate our complicated would be eligible to receive $1,200 in tax credits. systems. Together, Chairman Price and Seema Verma are the When Dr. Price reintroduced his plan, HR 2300, in May, dream team that will transform our healthcare system for the he said: “The Empowering Patients First Act puts patients, benefit of all Americans." families, and doctors in charge by focusing on the principles “I look forward to helping him tackle our nation’s daunting of affordability, accessibility, quality, innovation, choices and healthcare problems in a responsible and sustainable way,” she responsiveness. said. Verma received her master’s degree in Public Health, “Those principles form the foundation of the solutions with a concentration in health policy and management from in HR 2300 – solutions including individual health pools University, and her bachelor’s degree in Life Sciences from the and expanded health savings accounts, tax credits for the University of Maryland. purchase of coverage and lawsuit abuse reforms to reduce the Verma, who is a longtime supporter of Vice President-elect costly practice of defensive medicine. The solutions in the Mike Pence, is the architect of the Healthy Indiana Plan Empowering Patients First Act will get Washington out of (HIP), the nation's first consumer-directed Medicaid program the way while protecting and strengthening the doctor-patient under Gov. of Indiana and then-Gov. Pence's HIP 2.0 waiver relationship.” proposal. His plan would also allow people to opt out of Medicare Based in Indianapolis, she has supported Indiana through and Medicaid and receive a tax credit to buy insurance on the development of the historic program since its inception in 2007, individual market. That has brought Price closer to House from development of the enabling legislation, negotiating the Speaker Paul Ryan (R-Wis.) who has proposed a similar financing plan with the state's hospital association, developing privatization of Medicare. Dr. Price was one of the House GOP the federal waiver, supporting federal negotiations and leading committee chairs to help Speaker Ryan draft the “A Better the implementation of the program, including the operational Way” proposal as an alternative to the ACA earlier this year. design. For nearly 20 years, Dr. Price worked in private practice as an For more than 20 years, she has worked extensively on a orthopedic surgeon. Before coming to Washington he returned variety of policy and strategic projects involving Medicaid, to Emory University School of Medicine as an assistant insurance and public health, working with governors' offices, professor and medical director of the Orthopedic Clinic at state Medicaid agencies, state health departments, state Grady Memorial Hospital in Atlanta, teaching resident doctors departments of insurance, as well as the federal government, in training. He received his Bachelor and Doctor of Medicine private companies and foundations.
REACTION Reaction to Dr. Price’s nomination went along party lines. While House Speaker Ryan said in a Twitter post that Dr. Price is the “absolute perfect choice for HHS secretary," incoming Senate Minority Leader Charles Schumer, D-N.Y., said in a statement that Price doesn’t represent what Americans want when it comes to Medicare, the ACA and Planned Parenthood. He also said Dmocrats will try to block his nomination. In addition to dismantling President Barack Obama’s signature legislation, Forbes reports that Dr. Price could slow the healthcare industry’s transition to value-based care. The 62-year-old orthopedic surgeon has opposed Medicare’s mandatory bundled payment initiatives for hip and knee replacements. He has also criticized the implementation of the Medicare Access and CHIP Reauthorization Act. However, Dr. Price has also been vocal on health IT issues in Congress, according to Politico, which noted that he pushed for a doctor-friendly version of the law regulating the use of electronic health records. The American Medical Association issued a statement supporting his nomination. “Dr. Price has been a leader in the development of health policies to advance patient choice and market-based solutions as well as reduce excessive regulatory burdens that diminish time devoted to patient care and increase costs,” the AMA stated. The American Hospital Association President and CEO Rick Pollack noted that Dr. Price’s “clinical knowledge along with his congressional experience make him an impressively qualified candidate for HHS secretary.” The Healthcare Leadership Council, according to Fierce Healthcare, said it favors Dr. Price’s stance on overregulation. “Price’s work on health reform in the U.S. House exemplifies his commitment to patients and consumers as well as his understanding that the physician-patient relationship is paramount and must not be adversely affected by government action,” the group’s president, Mary Grealy, said.. College of Healthcare Information Management Executives President and CEO Russell Branzell pointed out that Dr. Price has championed health IT legislation aimed at reducing the burden on physicians and hospitals, including seeking greater flexibility in the Meaningful Use program that guides the transition to electronic medical records.. Debra Ness, president of the National Partnership for Women & Families, criticized his “abysmal record of leading the fight in Congress to dismantle the healthcare law that has expanded coverage to 20 million previously uninsured people.” Dr. Price’s ACA replacement proposals, which include health savings accounts, high-risk insurance pools and allowing interstate insurance sales, would significantly reduce access to care, drive up healthcare costs and diminish healthcare quality, Ness argued. Leading the charge from the left, the New York Timeseditorial board called Dr. Price “a man intent on systematically weakening, if not demolishing, the nation’s healthcare safety net.” VT N
DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
Not actual patients.
The essential NTNT choice. Offer a comprehensive GSV system solution for above and below the knee. VarithenaÂŽ (polidocanol injectable foam) 1% reaches veins that others canâ€™tâ€”treating a wide range of sizes and any vein shape including tortuous and varicosities above and below the knee. Varithenaâ€™s UDSS formulationâ€”uniform density, size and stabilityâ€”results in a long dwell time and thorough cohesion with the vein wall. Most importantly it addresses underlying YHQRXVLQFRPSHWHQFHLPSURYHVYHLQDSSHDUDQFHDQGVKRZVVLJQLĂ€FDQW352LPSURYHPHQWV ZLWKDQHVWDEOLVKHGVDIHW\SURĂ€OH1RZZLWKDGD\SRVWDFWLYDWLRQVKHOIOLIHWUHDWLQJ patients with VarithenaÂŽ is easier than ever.
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For more information on treatment, visit Varithena.com INDICATIONS VarithenaÂŽ (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. VarithenaÂŽLPSURYHVWKHV\PSWRPVRIVXSHUĂ€FLDOYHQRXVLQFRPSHWHQFHDQGWKHDSSHDUDQFHRIYLVLEOHYDULFRVLWLHV 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. VarithenaÂŽ 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, FRPPRQIHPRUDOYHLQWKURPEXVH[WHQVLRQVXSHUĂ€FLDOWKURPERSKOHELWLVDQGGHHSYHLQWKURPERVLV3K\VLFLDQVDGPLQLVWHULQJ9DULWKHQDÂŽ 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 VarithenaÂŽ
ÂŠ 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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Indication For Use: ClariVein® IC is intended for infusion of physician-speciﬁed agents into the peripheral vasculature. Rx Only. 510(k) Cleared by the Food and Drug Administration for commercialization in the USA. Contraindications: The ClariVein® IC infusion catheter is contraindicated for use in the coronary and cerebral vasculature, in the pulmonary vasculature, in diseased and artherosclerotic arteries; for infusion of blood or blood products; and for patients contraindicated for endovascular procedures. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions, and Potential Complications/Adverse Effects. Read and understand all labeling prior to use. Failure to do so may result in injury and/or device failure. The ClariVein® IC catheter is a single use, disposable device. Note: This material is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. This information is for use only in countries with applicable health authority product registrations. Contact your local representative for product availability in a speciﬁc country. M-077 (R1)
Akesys Med touts PRAVA scaffold to keep large artery open Akesys Medical, a drug-device company focused on pioneering innovative solutions for peripheral artery disease (P.A.D.), has announced its first clinical trial and successful implant of the new PRAVA Sirolimus Eluting Bioresorbable Peripheral Scaffold System for the treatment of blockage in the superficial femoral artery (SFA). The Akesys PRAVA scaffold is designed to maintain the large artery in the thigh open and restore blood flow to the leg, then resorb into the body and unlike metallic stents leave no permanent implant behind. The PRAVA scaffold leverages bioresorbable technology licensed to Akesys by Elixir Medical Corp., a developer of bioresorbable scaffolds for the coronary arteries, including the DESolve, DESolve Cx, and DESolve NXT platforms. According to the National Institutes of Health, one in every 20 Americans over the age of 50 has P.A.D., a condition that raises the risk for heart attack, stroke, limb amputation and death. More than 10 million people worldwide are estimated to have P.A.D. affecting the SFA. In order to combat this critical clinical need, Akesys Medical has partnered with Elixir Medical to conduct the DESappear Study. Drs. Marc Bosiers, vascular surgeon at AZ Blasius Hospital in Dendermonde, Belgium; and Dierk Scheinert, head of Department of Interventional Angiology at the University Hospital of Leipzig, Germany, will serve as principal coordinating investigators for the study. The DESappear Study is a prospective, single-arm, multicenter trial of the PRAVA scaffold in patients presenting with symptomatic atherosclerosis in the SFA. The primary
safety endpoint of the trial is a composite of freedom from perioperative death through 30 days and freedom from major adverse limb events (defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization) through a six-month follow-up. The primary effectiveness endpoint is primary patency defined as freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound (DUS)) or clinically-driven TLR (Target Lesion Revascularization) through 6 months. Clinical and DUS follow-up will be held at 30 days, and 6, 12, 24 and 36 months. Akesys Medical expects to enroll up to 60 patients at 12 sites in Europe and New Zealand. “The DESappear Study is an important milestone in the pursuit of bringing innovative therapies with state-of-the-art bioresorbable technologies to treat a vulnerable population of patients with P.A.D.,” said Dr. Bosiers. “I am excited to be working with Akesys Medical with the goal to bring this vital product to the clinic.” DESappear Investigator Dr. Andrew Holden, director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine, implanted the first PRAVA in a 66-year-old patient with 45 mm of disease in the mid-SFA and 80% blockage. “The diabetic patient with short distance leg claudication demonstrated zero percent residual stenosis following the
5 0RIIHUVYDULFRVHYHLQVWXG\ A new study, "Varicose Vein Treatment Market Analysis by Treatment Mode (Sclerotherapy, Endovenous Ablation, Stripping, Laser, Radiofrequency Ablation), and Segment Forecasts to 2024," has been offered by Research and Markets. The global varicose vein treatment market is expected to reach $475 million by 2024, according to this new report. The increasing technological advancements coupled with the increased availability of the advanced varicose vein treatment devices and shift towards less-invasive procedures are the contributing factors for the growth of the market. The huge burden of vascular diseases in Europe and North America and the increasing patient compliance and reliability, growth in healthcare expenditure, and the rapid growth in geriatric population is majorly driving the varicose vein procedure market. The upward trend in lifestyle disorders, such as increasing obesity, sleep disorders, blood pressure levels, hormonal changes, genetic disorders and pregnancy are the few major factors contributing to the peripheral vascular diseases. Untreated venous insufficiency, such as varicose vein and venous ulcers, cause progressive syndromes including chronic venous insufficiency. In 2015, according to FutSci, chronic veinous insufficiency is widespread and is a socially isolating condition caused in adults. It is the most common disease in the world and is estimated to affect 5 percent of the population in the Western countries. Key players of the market detailed in the report include Medtronic plc, AngioDynamics, Inc., Biolitec AG, Syneron Medical Ltd., Lumenis Ltd., Dornier MedTech GmbH, Energist Group, Eufoton S. R.L., Vascular Solutions Inc. and Quanta Systems S.p.A. Key topics discussed in detail in the report include: Methodology and scope, executive summary, varicose vein treatment outlook, varicose vein type outlook, varicose vein treatment regional outlook and a competitive landscape. VT N READ MORE: researchandmarkets.com/research/ntvf5c/varicose_vein
procedure with the PRAVA scaffold and has recovered well,” Dr. Holden said. “The PRAVA scaffold’s easy deliverability for treatment and its excellent structural support to the vessel without leaving behind a permanent metallic implant has the potential to transform treatment options for physicians like me to greatly enhance patient outcomes.” The PRAVA Sirolimus Eluting Bioresorbable Peripheral Scaffold System combines the distinctive attributes of excellent deliverability with robust vessel support, controlled drug release over six months and scaffold degradation within one year. These features of the PRAVA scaffold have been designed to address the unique challenges of the SFA where the high degree of mechanical force and deformation can pose challenges for permanent metallic implants including stent fracture, and irritation of the vessel wall potentially causing restenosis. In addition, the extended drug release of the PRAVA scaffold has the potential to sustain the initial clinical outcomes over the long term as compared to the suboptimal shorter duration drug-eluting balloons, and provide better vessel support post procedure. “Akesys is proud to have developed this important new therapy option for physicians to treat their patients suffering from debilitating peripheral disease,” said Motasim Sirhan, CEO of both Akesys Medical and Elixir Medical. “We are confident that the PRAVA scaffold system will meet the challenges of the SFA vasculature and demonstrate long-term, sustained results to become a valuable therapy in the treatment of SFA disease.” VT N READ MORE: elixirmedical.com
9DVFXODU6ROXWLRQVUHFDOOV Twin-Pass Dual Catheters Vascular Solutions has issued a nationwide recall of Twin-Pass Dual Access catheters because of a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapidexchange lumen. To date, no injuries have been reported in connection with the affected catheters, but the excess material can break free from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death, according to a Vascular Solutions release. The U.S. Food and Drug Administration posted the recall notice in October and is classifying this as a class I recall, for "a situation in which there is a reasonable probability that use of or exposure to a volative product will cause serious adverse health consequences or death." The Twin-Pass catheter contains two separate lumens and is designed to allow a guidewire to remain in place while the second lumen is used to deliver medication or contrast or to access the side branches.
Vascular Solutions voluntarily initiated the recall Sept. 16 through an urgent medical device recall notification that identified the specific lots and included instructions on how to return the affected devices. The company reported that 5,784 devices were distributed in the United States and that the condition that led to the recall may affect about 9.2 percent of recalled devices. A full listing of the recalled lots is available from Vascular Solutions and includes unexpired lots of model numbers 5200, 5210 and 5230, distributed from October 2014 to September 2016. Adverse reactions or quality problems experienced with use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program at: accessdata. fda.gov/scripts/medwatch/index. cfm?action=reporting.home. VT N
DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
NEWS VASCULAR SOLUTIONS continued from page 1
of a public medical device company," Root said Dec. 2. The acquisition allows Teleflex to pick up devices for minimally invasive coronary and peripheral vascular procedures and allows the company to gain entry into those markets. Teleflex operates across a range of areas, offering cardiac care, respiratory, interventional access and surgical products. The Vascular Solutions acquisition will boost Teleflex’s vascular and interventional divisions. Teleflex CEO Benson Smith said Vascular Solutions has established a strong franchise focused on interventional cardiology and interventional radiology which complements
Teleflex’s existing businesses. “ I m p o r t a n t l y, while we believe Vascular Solutions has compelling growth opportunities as they continue to build their business with their existing product portfolio, Howard Root we look forward to potential longer-term tailwinds as we benefit from their robust R&D pipeline and our international distribution network moving forward.” Teleflex has had a few problems this year. Despite having a couple of FDA clearances
this fall—for a midline catheter and a central venous catheter—the company has also recalled a mucosal atomizer, tracheostomy tube and 47,000 intra-aortic balloon catheter kits. Teleflex earned $456 million in the third quarter, up 2.7 percent year-over-year, and earned $1.8 billion for 2015, down 1.6 percent from the previous year. Last February, the company’s board approved a restructuring program to cut as much as $44 million in costs and “improve operating efficiencies.” This included layoffs, relocations and outsourcing. This followed the company’s previous “manufacturing footprint realignment” plan, which sought to do much the same. The company anticipated savings of between $26 and $31 million.
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But Smith noted that the deal would meet the company’s M&A goals, while also adding products that: • Allow for "synergy generation." • Provide a superior clinical benefit to existing alternatives and a cost benefit to hospitals. • Have long product life cycles that benefit from patent protection. • Enable the company to further improve its financial profile. Guggenheim Securities was the financial adviser to Vascular Solutions, while Dorsey & Whitney provided legal counsel. J.P. Morgan Securities advised Teleflex, while Simpson Thacher & Bartlett was legal counsel. VT N
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VEIN THERAPY NEWS DECEMBER 2016/JANUARY 2017
Illustration of the Trailblazer support catheter
Medtronic support catheter for P.A.D. gets FDA approval The FDA cleared Medtronicâ€™s angled support catheter for use in the treatment of peripheral artery disease P.A.D. Support catheters are used in endovascular procedures to treat P.A.D. Medtronicâ€™s TrailBlazer angled support catheter supports a guidewire in the peripheral arteries and allows the delivery of devices and diagnostic agents, Mark Pacyna, vice president and general manager of Medtronicâ€™s peripheral unit, said. The device comprises a braided stainless steel shaft and a 25- and 30-degree angled and tapered tip to negotiate complex lesions in the blood vessel, according to a statement. It is compatible with three different guidewire thicknesses: 0.014, 0.018 and 0.035 inches. The two smaller support catheters can fit through the largest one, which increases the reach of the device if needed. "Medtronic is committed to providing physicians with meaningful innovations and therapy choices to enhance their peripheral treatment algorithm," Pacyna said. "Working with physicians, we have extended the Medtronic TrailBlazer support catheter portfolio to offer a broad suite of angled options for treatment of complex lesions both above and below the knee." Medtronic recently announced promising two-year data for its IN.PACT Admiral drugcoated balloon for the treatment of tough P.A.D. cases. The data showed that the balloon can be effective in patient groups that typically donâ€™t respond well to balloon angioplasty: women and diabetics. Medtronic also markets the Arc support catheter for the treatment of acute ischemic stroke. It facilitates faster delivery of the companyâ€™s Solitaire stent retriever, which removes the blood clot during a stroke, restoring blood flow in the brain. VT N
AVF registering for 29th meeting The American Venous Forum (AVF), dedicated to improving the care of patients with venous and lymphatic disease, has opened
registration for the 2017 Annual Meeting Feb. 14-17 at the Hilton New Orleans Riverside Hotel. The objective of this comprehensive 29th meeting is to provide attendees with knowledge of current thinking in effective clinical management of venous disease and insight into the future directions from critical analysis of investigative findings. Founded in 1987, the AVF fosters cutting edge research and clinical innovation and educates health care professionals, patients and policy makers about venous and lymphatic diseases. AVFâ€™s leadership and membership are recognized internationally as thought leaders, expert investigators and clinicians in venous and lymphatic health care. The purpose of this 29th annual meeting is to provide attendees with knowledge of current thinking in effective clinical management of venous disease and insight into the future directions from critical analysis of investigative findings. The 2017 program schedule is available at dropbox.com/s/bb6ux0d3hrc07dh/ AVF%202017%20Program%20at%20a%20 Glance%20111416.pdf?dl=0 . Register at crm.veinforum.org/public/event/ details/4f4fc5f6ab5d03a96a8ddd65fdfd1932d c2c09a4 Tuesday, Feb. 14, will be the 2017 Day of Innovation and Science, an all-inclusive forum for scientific exchange aimed on defining current research priorities in the area of Venous and Lymphatic Diseases. VT N Register separately at crm.veinforum. org/public/event/details/57af1217d ccd45230a99fb092c868487f3c8f6a6.
Vascular closure devices market to grow 8% to 2020 Technavio analysts predicts that the global vascular closure devices market will grow at a CAGR of more than 8 percent from 2016 to 2020. The new available research study, â€œGlobal Vascular Closure Devices Market for 2016-2020,â€? covers the present scenario and growth prospects. The report also presents the vendor landscape and a corresponding detailed analysis of the top four vendors operating in the market. In addition, it discusses the major drivers influencing market growth and the challenges faced by vendors and the market as a whole. Technavio healthcare and life sciences analysts highlight the following three factors that are contributing to the growth of the vascular closure devices market: â€˘ Incidence of cardiac diseases and adoption of interventional cardiac catheterization â€˘ Minimally invasive procedures with improved medical imaging
3HQXPEUDKLJKOLJKWVSHULSKHUDO YDVFXODUWHFKQRORJLHVDW 9(,7+V\PSRVLXP$,0V\PSRVLXP Penumbra, a global interventional therapies company, was highly visible at the 24th AIMsymposium, which was, held Nov. 14-17, and at the 43rd VEITHsymposium, which was Nov. 15-19 in New York. Penumbra highlighted its peripheral vascular technologies, and final results of the multicenter PRISM study, designed to assess the safety and efficacy of the Indigo System for peripheral and visceral arterial thrombi and emboli, were presented. The Indigo System is a mechanical aspiration system for the removal of emboli and thrombi in the peripheral vasculature. PRISM, which began in 2014, evaluated the use of the Indigo System for patients with peripheral occlusions secondary to acute ischemia, incomplete reperfusion and procedure-related distal emboli, using primarily the systemâ€™s smaller size catheters, according to James Benenati, MD of the Miami Cardiac & Vascular Institute. â€œMulticenter Retrospective Analysis of Results of Penumbra Indigo System for Mechanical Clot Aspiration from Arteries: How It Works, Indications, Vessel Sizes and Decreased Need For Lytics: The PRISM Registryâ€? was presented by Dr. Benenati on Nov. 17. Penumbra showcased its growing portfolio of peripheral vascular technologies at its booth, including its latest enhancement to the Indigo System, the Advanced Separator, which is offered with the larger size separator and designed to be more robust and supportive for clot extraction in larger arteries and veins in the periphery. Penumbra also featured its embolization product line: Ruby Coil, POD, POD Packing Coil and LANTERN, a low-profile, high flow coil delivery microcatheter. Penumbraâ€™s embolization and thrombectomy devices were highlighted in several podium presentations throughout the week: â€˘ â€œUse of the Indigo Device for Acute DVT: Replacing Thrombus Dissolution with Thrombus Extractionâ€? was presented by Patrick Muck, MD, of Good Samaritan Hospital in Cincinnati, Ohio, on Nov. 15. â€˘ â€œAdvantages of The Indigo Thrombectomy Device from Penumbra to Treat ALI â€“ How does it Get Clot Out More Effectively: Does It Have Disadvantages or Limitationsâ€? was presented by Dr. Muck on Nov. 16. â€˘ â€œWhy the Indigo Catheter Mechanical Thrombectomy System is a Better Way to Remove Clot and Debris from Blood Vessels and Decrease the Need for Lytic Drugsâ€? was presented by Frank Arko, MD, of Sanger Heart & Vascular Institute in Charlotte, N.C. on Nov. 17. â€˘ â€œValue of Indigo Thrombus Aspiration System in Acute Limb Ischemia and Visceral Artery Thromboses or Emboli: Why it is a Game Changerâ€? was presented by Dr. George Adams of the University of North Carolina Medical Center in Raleigh and Chapel Hill, N.C., on Nov. 17. â€˘ â€œUse of the LANTERN Microcatheter and Ruby and POD Coils (Penumbra) for Arterial Embolization: What Are Their Advantages and Limitations?â€? was presented by Aaron Fischman, MD, of the Mount Sinai Medical Center in New York on Nov. 17. Penumbra also hosted a lunch symposium on Nov. 16. The symposium included presentations on Penumbraâ€™s peripheral vascular technologies by Dr. Arko and Dr. Benenati. Penumbra also participated in hands-on workshops where physicians joined in discussions with experienced users and utilized Indigo System, Ruby Coil, POD, POD Packing Coil and LANTERN in simulated models: Venous Workshops Nov. 16 at VEITHsymposium, Module 2: DVT Treatment (featuring the Indigo System); AIMsymposium Workshops / Case Presentations (featuring Indigo System, Ruby Coil, POD, POD Packing Coil and LANTERN; PVD, Embolization, IVC Filters, TACE/Radioembolization; and Venous / Lymphatic Intervention. VT N READ MORE: Penumbrainc.com
â€˘ Popularity of femoral arterial cardiac catheterization. The incidence of cardiac diseases is on the rise worldwide. In 2015, the CDC estimated that cardiac diseases caused about 610,000 deaths in the United States. The organization
also estimates that coronary heart disease was the most common cardiac disease, causing 375,000 deaths in the US annually. As a part of treatment for coronary heart disease, physicians perform coronary angiography and percutaneous coronary
DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
NEWS intervention (PCI) for diagnosis. These procedures help confirm the severity of the disease, allowing physicians to prescribe further treatment plans. The procedure involves the insertion of the catheter in the femoral or radial artery to access the heart for determining the severity of the disease. Physicians can also perform angioplasty, which is a part of primary PCI, for treating narrowed coronary arteries caused due to chronic heart diseases. The procedure involves the insertion of balloon catheters through the groin or arm and threaded through the arterial system to reach the heart or coronary artery. The insertion of the catheter during diagnosis and angioplasty can cause vascular injuries, which leads to bleeding. To stop the bleeding, physicians use vascular closure devices for closing the arterial site. According to Srinivas Sashidhar, a lead analyst at Technavio for cardiovascular devices research, the rise in the cases of cardiac disorders will lead to an increase in the number of interventional cardiac catheterization procedures, which will increase the demand, sales and use of vascular closure devices for the stoppage of bleeding. Medical facilities worldwide are shifting toward minimally invasive procedures that involve the use of radiotherapy and imaging technologies, expanding the treatment options for peripheral vascular diseases such as deep vein thrombosis. To treat the disease, physicians use angioplasty or insert stents in the blood vessels through small incisions by minimally invasive surgeries. Radiologists who use interventional angioplasty to thread catheters or stents to the femoral artery also adopt minimally invasive procedures. These procedures help minimize trauma and pain and reduce the risks of infection in the blood vessels. Minimally invasive surgeries sometimes are assisted with MRI technology for medical imaging. This technology helps detect internal injuries and allows better diagnosis and understanding of the injury, particularly during cardiovascular and neurovascular surgeries. The use of these imaging techniques for monitoring heart functions will increase the demand for cardiac surgeries, particularly minimally invasive technology-based surgeries. Minimally invasive surgeries along with MRI technology offer improved imaging and better insertion of vascular closure devices, which will increase their sales and demand. The implementation of femoral arterial cardiac catheterization is the highest among all vascular access procedures. Interventional cardiac procedures such as angioplasty involve the use of a balloon catheter to puncture the femoral artery in the groin to remove the blockage in the blood vessel. VT N READ MORE: technavio.com
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Are you engaged while completing patient EHR? By Nat’e Guyton, RN, PhD, MSN, CPHIMS, NE-BC The last time I was in a physician’s office was a few months ago, when my family had a very important decision before us to have my teenage son undergo a major surgical procedure. During this visit, I had to actually make the request that the doctor put his computer away while we were going through the conversation. It was a serious decision and I wanted everyone to be engaged – especially the provider responsible for my son’s care plan. I didn’t feel like I could establish that trust that is so critical to the doctor/patient relationship (and doctor/family relationship) without him looking me in the eye and meaningfully focusing on the conversation. While this experience frustrated me, it did not surprise me. It’s a common patient frustration in 2016: Northwestern University researchers discovered that physicians using EHRs spent about a third of patient visits looking at their screens. And all of that screen time can negatively affect the patient experience: A JAMA study published earlier this year found that patients rated the care they received lower when doctors looked at a computer screen a lot during patient examinations. Technology – from PCs and tablets to smartphones and wearables – has continuously increased its presence in healthcare. Overall, this is a good thing. Technology can streamline clinical workflows and improve care team communication. However, it’s also inhibited the human side of medicine. As a clinical leader in hospitals and health systems, I was often asked “How do I ensure personal patient interactions while using a mobile device at the bedside?”
Doctors want to give their undivided attention to the patient but face many pressures to log information into the EHR in real time in order to document for charge capture, reimbursement and a host of other things. Oftentimes entering information into the EHR can spur questions for the physician to ask the patient as well, and the prompts can add value to the visit. When 98 percent of hospitals have an EHR system, it’s clear they aren’t going away. The trick is, then, to find a satisfactory answer to this question: “How can doctors co-exist with technology and still maintain that very human and personal doctor/patient relationship?” I’ve seen physicians who achieve the best balance they can in the digital environment we’re all working in by doing a couple of different things. First, they practice mindfulness by just being cognizant that technology can be a barrier and making adjustments to engage the patient. For example, some doctors position themselves, the patient, and the screen into a triangle and do their best to talk the patient through what they are doing and recording. Indiana University School of Medicine Professor of Medicine Richard Frankel, Ph.D, has developed a model he calls POISED for developing and reinforcing good use of screen time, which includes sharing, educating and other good practices that he says can actually save time. It doesn’t eliminate screen time by any means, but it does help balance the need to document with the need to build and maintain the relationship with the patient. Second, they use other technologies besides the EHR to their advantage. PCs and mobile devices often fight for our attention with screen pop-ups, beeps and buzzes. Many doctors set boundaries on those interruptions where they can to avoid any screen distractions that aren’t pertinent to the visit.
They might turn in-basket pop-ups when the patient record is full-screen. Or they might set their Spok Mobile status to “Do Not Disturb” when they are having a serious conversation with a patient. Other physicians love their smartwatches because they can adjust their settings so incoming messages have a soft vibrate that’s perceptible only to them, allowing them to quickly glance at messages and ignore them if it’s not something they need to respond to immediately/while they are with the current patient. I understand it’s not an easy task, and the doctors I speak with certainly understand the patient frustrations. By intentionally being cognizant of eye contact and focus, sharing and educating the patient on the documentation as you go, and using the available communications technology to minimize unnecessary disruptions, we can do our best as caregivers to keep the focus on the patient while using the technology to benefit their care. By working toward a peaceful co-existence with technology and balancing screen time with face-to-face interaction, you provide the requisite care, as well as the attention and compassion that’s needed to establish trust. VT N Nat’e Guyton, RN, PhD, MSN, CPHIMS, NE-BC, is Spok’s Chief Nursing Officer. She is a nurse and clinical leader with more than 15 years of healthcare and technology experience that includes clinical workflow redesigns, EHR and health IT. Guyton holds a bachelor’s and master’s degree in nursing, post graduate degrees in healthcare administration and healthcare informatics, and a doctorate in management-organizational leadership. She is an advocate for patients, for nurses and for healthcare organizations. She can be reached at email@example.com.
(DVLHVWWRXQGHUVWDQGPHGLFDOELOOVDZDUGHG The Department of Health and Human Services (HHS) has announced the winners of the HHS "A Bill You Can Understand" challenge, a design and innovation challenge to solicit new approaches and draw national attention to a common complaint with the health care system: that medical billing is a source of confusion for patients and families. HHS received submissions from healthcare organizations, technology companies and design agencies, and they selected two winning designs, which will be further evaluated for testing or implementation in six healthcare organizations across the country that are working to improve the patient billing experience. “One of our priorities is to put patients at the center of their own health care,” said Secretary Sylvia M. Burwell. “Helping Americans understand their medical bills empowers them to take more control of their health, and that’s a step in the right direction for our entire health care system.” After receiving more than 80 submissions, the challenge awarded two prizes for: the bill that is easiest to understand; and the design that best improves the overall approach to the medical billing system, focusing on what the patient sees and does throughout the process. Prize 1 was awarded to RadNet of Los Angeles. RadNet’s design aims to make the bill as concise as possible. RadNet provides adaptable bills that line up with the patient’s current
It looks like you have no balance due! You will not be receiving a paper bill for any current charges.
Easiest bill to understand experience, including options for uninsured patients and for patients who are past due on payments. Their use of color segments make it easy for patients to locate and read specific information, and the bill includes a clear presentation of payment due, payment options, and insurance details. Additionally, plain language explanations put charges in context. Prize 2 was awarded to Sequence of San Francisco. Sequence developed “Clarify,” a new online- and mobile-based service that extends a retail model of consumer behavior to medical billing. “Clarify” presents healthcare services in new ways that allow people to search, browse, weigh their options, compare prices and decide how they will pay. By modernizing, automating and personalizing the transactional aspect of
healthcare services, “Clarify” could enable better relationships among consumers, providers, and payers. The winning designs and honorable mentions can be viewed at abillyoucanunderstand.com. The “A Bill You Can Understand” challenge was sponsored by AARP and administered by the design agency Mad*Pow. As part of the challenge, the following organizations have committed to work with the developers on their winning billing solutions to consider testing or implementing for the patients they serve: • Cambia Health Solutions (Portland, Ore.) • Geisinger Health System (Danville, Penn.) • INTEGRIS Health (Oklahoma City, Okla.) • The MetroHealth System (Cleveland, Ohio) • Providence Health & Services (Seattle, Wash.) • University of Utah Health Care (Salt Lake City, Utah) VT N
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DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
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PIECES OF THE ERGONOMICS PUZZLE 0XVFXORVNHOHWDOGLVRUGHUVDPRQJVRQRJUDSKHUVLQFUHDVHULVNRISDLQLQMXU\ By Carolyn T. Coffin MPH, RDMS, RVT, RDCS Technological advances have resulted in vascular ultrasound labs becoming more efficient and productive; but they have added to the risk for worker pain and injury. High rates of work-related musculoskeletal disorders (WRMSD) among sonography practitioners are creating concern over patient care and staffing. The increased incidence of WRMSD among these workers is due to several factors, and the causes of these injuries are multifactorial
(Bongers, et. Al., 1993) Finding the pieces of this puzzle can be challenging; but, the pieces fall into three categories. One category relates to exam schedules and administrative support. Another category focuses on the individual worker and his or her willingness to make postural changes and to learn about the mechanisms of occupational injury. And, the third category includes the components of the workstation and the work environment. An ergonomically designed workstation is one solution for minimizing worker injury in the vascular ultrasound lab. The effect of ergonomically designed equipment can result in increased productivity and quality of
patient care, decreased number of lost work days, fewer worker injuries and a reduction in insurance costs). Educating workers in how they can make changes in their work postures is one puzzle piece in the path to reducing injury risk. Workers can also be taught how to use their current equipment in more ergonomic ways, even if that equipment has limited ergonomic features. Learning to use the ergonomic features of their new equipment is also an important part of reducing injury risk. Risk factors for WRMSD include forceful exertions, awkward postures and prolonged static postures, and â€œpinchâ€? grip of the transducer. The accumulated exposure to one or more of these risk factors over time leads to injury because repeated exposure interferes with the ability of the body to recover. These injuries cause pain, inflammation, swelling, deterioration of tendons and ligaments and spinal degeneration.
that is easily and quickly adjustable allows workers of different heights to position the table so that reach and arm abduction are reduced. Seated posture is often not given enough importance. Sitting unsupported increases pressure on the lumbar intervertebral discs 40 percent over the pressure from standing. Forward flexion and rotation of the trunk increase the pressure on the lumbar spinal discs by 400 percent (Valachi, 2003). These positions are frequently assumed by practitioners during patient exams or while working at computer workstations. Chairs or stools that provide trunk support and proper spinal alignment can reduce oneâ€™s exposure to injury. Adjustable chairs allow the practitioner to comfortably reach the work area while seated. Ergonomic seat design reproduces the normal standing position in which the spine has a natural curve. This curve should be maintained even while
Many practitioners are forced to stand because the exam table is not adjustable. This puts significant strain on the cervical and thoracic spine, hips and knees.
Muscles and joints are further stressed once their support structures are weakened. Sustained awkward postures can cause imbalances between the muscles that move and the muscles that stabilize. Prolonged static postures, whether sitting or standing, increase the load on soft tissues and the compressive forces on the spine. Additionally, the contraction of more than 50% of the bodyâ€™s muscles is required to maintain static postures (Valachi, 2003). State-of-the-art workstation equipment is designed to be adjustable in order to accommodate different practitionersâ€™ size and work style and facilitate more natural body postures. For example, exam tables that are not height adjustable force the practitioner into postures that can lead either to spinal degeneration from bending or shoulder injury from extended reaching. Many practitioners are forced to stand because the exam table is not adjustable. This puts significant strain on the cervical and thoracic spine, hips and knees. If the body weight is not evenly distributed on both feet, or the procedure requires standing for prolonged periods of time in a fixed position, strain on the hip joint increases which may result in joint degeneration. An exam table
leaning forward on the seat. While sitting in a conventional chair, the spine is forced into an unnatural, flattened position. Additionally, ergonomic chairs promote movement so that adequate circulation to the muscles is maintained. Human physiology depends on movement which promotes normal muscle contraction and relaxation. Muscle activity circulates blood to carry nutrients to and remove toxins from muscles. Awkward and static postures cause muscles to continuously be contracted; and therefore, they cannot receive oxygen or get rid of toxins (Kroemer, 2000). Other significant components in the workstation are arm support devices. This support can be as simple as a roll-up towel, a cushion or a more complex device that supports the arm. When the arm is abducted without support, the shoulder muscles will have to fire continuously in order to support the arm. The ideal angle of abduction is no more than 30 degrees, which is often difficult to obtain during a vascular ultrasound exam or interventional procedure. A 30-degree angle of abduction can be maintained for about 60 minutes before fatigue occurs. At an angle of 60 degrees, muscle strength can be reduced to
DECEMBER 2016/JANUARY/2017 VEIN THERAPY NEWS
SECONDLOOK 30 percent of a worker’s maximum strength level (Kroemer,2000). Muscle firing can be reduced by reducing arm abduction and providing arm support. During exams or procedures where arm abduction cannot be effectively reduced, arm support becomes even more critical. Having modern, ergonomically designed workstation equipment is only as good as the practitioner’s willingness to learn how to use the features and why they are important. These two puzzle pieces – workstation equipment and user-interface training – can provide a large part of the solution to the WRMSD puzzle. Reducing these injuries makes good economic sense in the long run and preserves a competent, efficient and injury-free workforce in the vascular lab. VTN 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.
Finding the pieces of this puzzle can be challenging; but, the pieces fall into three categories.
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REFERENCES Bongers, P.M., deWinter, C.R., Kompier, M.AJ., Hildebrandt, V.H. (1993). Psychosocial factors at work and musculoskeletal disease. Scandinavian Journal of Work Environment & Health, 19 (5), 297-312. Kroemer, K., Grandjean, E.,(2000). Fitting The Task to the Human, (5th ed.), Taylor & Francis, Inc., Philadelphia. Valachi, B., Valachi, K.,(2003). Mechanisms leading to musculoskeletal disorders in dentistry. Journal of the American Denistry Association, October (134), 1344-1350.
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SECONDLOOK COMPOUNDING continued from page 1
finished sterile product, must have potency, sterility and endotoxin testing completed and documented. As well, the pharmacy will have on hand a certificate of analysis available for each ingredient used in the sterile compound. Some of the “facts” presented were incorrect. The question was asked whether the FDA has jurisdiction over compounding pharmacies and was answered, "pharmacies are not inspected by the FDA." The FDA can, and does, inspect any pharmacy compounding sterile medications. These inspections are routine and unannounced. Dr. Morrison also spoke about interstate shipping, stating "if they (compounding pharmacies) start operating so that they are,
Adhering to USP 797, a pharmacy, when dispensing a finished sterile product, must have potency, sterility and endotoxin testing completed and documented. As well, the pharmacy will have on hand a certificate of analysis available for each ingredient used in the sterile compound. for example, shipping to other states, that starts to become more of a problem." Interstate shipping is legal, not a problem or concern, provided the pharmacy is properly licensed in the state to which they are dispensing prescriptions. The "studies" presented to back up Dr. Morrison's opinions were from as long as 15 years ago and the methods used for these studies were never scrutinized. One study clearly stated that samples were obtained through Internet marketing pharmacies. This is hardly representative of pharmacies that are USP 797-compliant, performing all potency, sterility and endotoxin testing prior to dispensing any medication. One study was sponsored by a manufacturer of a commercially available product, which seems less than objective.
Interstate shipping is legal, not a problem or concern, provided the pharmacy is properly licensed in the state to which they are dispensing prescriptions. Objective analysis is critical, especially concerning the testing performed on compounded medications. Pharmacies using a FDA-registered laboratory to perform analysis are committed to quality for both physicians and their patients. FDA-registered laboratories conform to all federal regulations, including current good manufacturing practice (cGMP) requirements, and provide pharmacies an additional layer of oversight and monitoring of quality controls, testing processes and procedures. Dr. Morrison also stated that compounding pharmacists would withhold information, make false claims that their products were FDA-approved when they are not, and he made the blanket statement that "all the pharmacists lie." I don't think that Dr. Morrison intended to call an entire medical profession "liars," as that would be irresponsible and unprofessional. There are certainly people in many professions, including doctors, who are unethical and even incompetent. However, to paint the entire profession with the same brush is wrong, and does an extreme disservice to the accuser as well as the accused. It is true that compounded products are never "FDA approved." Dr. Morrison may have misinterpreted the statement that compounding pharmacies are required by
...compounding pharmacies are required by state pharmacy law to receive ingredients from an FDA-approved wholesaler. The above documentation is always available for a prescriber to request and review.
(',725¬6127( On Oct. 12, I listened to the ACP-sponsored webinar by Dr. Morrison. In the presentation, I wasn’t hearing anything new until someone asked this question: “Can you request control from the compounding pharmacy regarding materials used and who produced the drug itself?“ Dr. Morrison replied: “Good Luck!! I’ve tried that and I’ve questioned the people very, very carefully and when I go to them they typically can’t answer the questions or they certainly don’t answer them to my satisfaction. They don’t want to really answer the questions and that’s where you run into problems. “Another problem is compounding pharmacies will flat out lie to you and tell you they have FDA-approved drugs when they do not. So trying to get information from the pharmacies, even for example, I tried to find out if they were using pharma grade or commercial grade and while they would assure me that they were using pharma grade would not produce a document telling me that. They would only tell me they were using FDA-approved stuff but they wouldn’t prove it.” “So that’s my take: All compounding pharmacists lie.”
state pharmacy law to receive ingredients from an FDA-approved wholesaler. This doesn't make a product FDA approved; it simply means the product was made with ingredients manufactured in an FDA-approved facility. The above documentation is always available
to success. Dr. Haulsee's experience is gained through his involvement within many facets of the pharmaceutical industry; manufacturing to wholesale to retail. Dr. Haulsee has owned pharmacy businesses worldwide, developed pharmaceutical manufacturing companies,
Objective analysis is critical, especially concerning the testing performed on compounded medications. FDA-registered laboratories conform to all federal regulations, including current good manufacturing practice (cGMP) requirements, and provide pharmacies an additional layer of oversight and monitoring of quality controls, testing processes and procedures. for a prescriber to request and review. The only information that is not shared is proprietary formulations. In summary, I was disappointed to see a presentation that lacked accurate information about the options available to physicians. I would encourage physicians to speak directly with their pharmacy to get answers to any questions regarding compounding, testing or any other concerns. VT N Michael Haulsee, PharmD, is CEO and founder of TCS Coaching and Business Consulting. From his early days as a clinical pharmacist to international consultant, Dr. Haulsee has developed a keen understanding of the complicated dynamics that can affect effective business. His unique method to empower a client encourages solution development that leads
assisted in the successful formation of international specialty pharmacies, and has become keenly knowledgeable of foreign cultural and regulatory differences. See tcsconsults.com for more information.
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DECEMBER 2016/JANUARY/2017 VEIN THERAPY NEWS
SECONDLOOK 6,*9$5,6RIIHUV anti-embolism VWRFNLQJOLQHWR KHOSVWRS'97V Today’s patients are encouraged to be up and moving as soon after surgery as possible. With this in mind, SIGVARIS has created a new line of anti-embolism stockings to help prevent a deep vein thrombosis (DVT) during bed rest and provide the benefits of graduated compression when transitioning from recovery to early rehabilitation. The SIGVARIS Anti-Embolism Stockings are available in both calf-length and thighhigh styles and feature an open toe design that allows for easy inspection of the feet, while an anatomical foot design makes it easy to wear these stockings with shoes when transitioning from the bed to physical therapy.
These stockings feature 18–23mmHg of graduated compression and a comfortable top band that stays in place. It is also latex-free to prevent skin irritation. Scot Dubé, president and CEO for SIGVARIS North America, said the fabric is extremely soft to provide extra comfort for patients. Products are designed to be tightest at the ankle and decrease in pressure going up the legs, improving circulation and providing relief for tired, achy legs. “It has been documented that up to 60 percent of blood clots develop during or after hospitalization (worldthrombosisday.org),” Dubé said. “Bedridden patients and those who are undergoing surgery should ask their physician about wearing anti-embolism stockings to help aid in the prevention of a DVT.”
DVTs can break loose and cause a pulmonary embolism, which has the potential to become fatal. “Over the years, many professionals have asked us about anti-embolism stockings,” Dubé said. “With so many people benefiting from wearing graduated compression daily, this product makes it easy to talk to patients about how to prevent DVTs post-surgery, as well as the importance of taking steps to keep legs healthy every day.” Wearing graduated compression can dramatically help improve overall leg health by increasing circulation to keep legs looking and feeling their best. VT N READ MORE: sigvarisusa.com
SIGVARIS has created a new line of anti-embolism stockings (right).
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SECONDLOOK NEW CPT CODES continued from page 1
he or she treats the first vessel in the leg with MOCA, she explained. The second code – CPT 36474 – is billable if he or she treats any additional vessels with MOCA in the same treatment session. “What’s interesting about these two codes is that they completely mirror the structure and description of codes that already exist for ablation of the lower vessels, namely radiofrequency ablation and endovenous laser ablation techniques,” she said. “This is reflected in the overall reimbursement parity of all three procedures.”
WHO DRIVES CODE CREATION? But the codes did not come with the invention of the ClariVein device nor were they requested by Vascular Insights, the maker of ClariVein. Dr. Elias, director of the Centers for Vein Disease at Englewood Hospital and Medical Center in New Jersey and Sovereign Health Systems, said there is a misconception that the industries that develop drugs or medical devices are behind getting new CPT codes adopted. “Although, they certainly have an interest in this getting accomplished, they do not get the codes created,” he said. “It starts with doctors who use the device talking to other doctors who use the device. “When a new code comes out, it is because a number of medical societies associated with treating that disease initiate and drive the process that results in the code being published,” Dr. Elias said. “Their members who have used the device believe that there is strong enough data that the technique or device deserves its own code so it can be used in the right clinical setting for patient care and the doctor can get reimbursed.” Renbaum agreed with Dr. Elias that there is a misconception about who drives the code creation. She said it really starts as a grass roots effort by physicians. “Doctors who are members of a medical society communicate with their society’s leadership and say, ‘Hey, we need a new code for this service. We need a way to bill that’s not relying on any other procedure code.’ Once that kind of feedback reaches the society’s leadership responsible for new code development, that group then develops the application and helps obtain and present all the supporting evidence. “But the reason a new CPT code is being developed in the first place is because of physicians who ultimately want to bill and be paid properly for the work they do. So it all came from the demand from the physicians,” she said.
CPT 36473 and CPT 36474 2017 Current Procedure Terminology (CPT) 36473: “Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated,” and CPT (add-on code) 36474: “Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites.” These two new Category I CPT codes are approved and finalized by the Centers for Medicare and Medicaid Services (CMS) in its calendar year 2017 Final Medicare Physician Fee Schedule (MPFS).
SCHEDULE (MPFS)1 These CPT codes describe the third and newest approach to a long-standing treatment modality: endovenous vein ablation for treatment of chronic venous insufficiency in the lower extremity. CMS established payment parity for this ablation technique, which does not require thermal energy – called non-thermal, non-tumescent ablation (NTNT), with existing thermal ablation treatments (e.g., radiofrequency and endovenous laser ablation devices that require thermal, or heat-based energy, to ablate and destroy the diseased veins), acknowledging the comparability of time and resources necessary to deliver any of the ablation techniques. CMS has aligned the payment policies for mechanochemical ablation with its precedent ablation procedures in both the Final MPFS and Final Medicare OPPS Rules; policies that will become effective on Jan. 1, 2017.
FINAL 2017 CMS Total Relative Value Units (RVU): Thermal and Non-Thermal Ablations CPT Code
Endoven. mechanochem. ablation, (1st vein)
+ Add-on (subsq. vein)
Endoven. radiofreq. ablation (1st vein)
+ Add-on (subsq. vein)
Endoven. laser ablation (1st vein)
+ Add-on (subsq. vein)
APC Total RVUs APC (NonPayment: Payment: ASC Facility) HOPD (#5182) 42.42
7.77 43.07 8.39 34.10 8.81
The new Category I CPT codes, along with reimbursement, provide strong validation of the need, expected utilization and likely switching to NTNT ablation modalities by providers. VT N
HOW A CODE IS CREATED Renbaum explained that creating a new category 1 CPT code is a multistep process that begins with the respective specialty societies that that want to create the code. The societies review all the literature and many other factors, and put together the critical case for why the procedure merits its own code, and that it is a procedure or device that has been tested and merits a code. “The AMA owns and maintains the CPT code set. So specialty societies submit their
request to the AMA’s CPT editorial panel, which then solicits feedback from advisors from more than 100 societies representing physicians and other qualified healthcare professionals,” Renbaum said. “The CPT review process is fairly transparent and consistent. Reviewers check to be sure there is appropriate FDA clearance, that it meets a certain level of clinical evidence and that there is some significant utilization so that when it is rolled out across the country, it actually gets used on a regular basis.”
The societies that worked together to create CPT codes 36473 and 36474 included the Society for Vascular Surgery (SVS), Society for Interventional Radiology (SIR), American College of Phlebology (ACP) and American Venous Forum (AVF). The American College of Cardiology (ACC) also supported the application. “So what is initially approved in this process is a description of the code itself; that is, how the doctor performs the mechanochemical ablation technique,” she explained. “And then it goes to another committee of the AMA, which determines its actual value. That ultimately translates into the dollars that Medicare will pay when a physician bills that code. “Assigning the relative valve units (RVUs), the units of work and the costs of medical expense associated with every CPT code that can be billed by a physician’s office is a rigorous process led by the same societies. Their proposal is again presented to their peers and colleagues for review of the cost of delivering the service. There’s extensive physician input on the work and effort that is required.” Once that process is completed, the AMA subcommittee presents its recommendations to Medicare for how many RVUs that new code should have. Renbaum said Medicare then reviews the recommendation and can accept it or change it in any way they see fit based on their own analysis of the work and cost involved, and then they announce what they plan to pay in a proposed rule. That is when the public can find out there is going to be a new code and what the proposed payment for that code will be. After a twomonth period of public review, the final rule is published in the Federal Register. “It’s a very rigorous, comprehensive, extensive process that can take 18 months to three years,” Renbaum said. Medicare updates its payment rules for physician services for all 600,000-plus physicians every year and they do that by adding any new codes that have been developed and approved through the AMA in the previously described review cycle. “So Medicare basically rebalances all of these factors to follow all of the legislative requirements it has of budget neutrality,” she said. “Details about physician quality, metrics and payment variables associated with all the quality goals that Medicare has in place for physician services are also included.”
WHY CODES ARE IMPORTANT Dr. Elias said that in general, every device and procedure has its own situation where it is of better use than other procedures. This is critical to patients because the doctor can choose from all tools what is best for that patient in that situation. It might seem
DECEMBER 2016/JANUARY/2017 VEIN THERAPY NEWS
SECONDLOOK that this procedure code just benefits the physician’s billing and reimbursement, but it actually removes the barriers to using what is best for the patient. “It allows the physician to use MOCA or the ClariVein device in those clinical situations when they feel that it’s important to have a device like this for use. In the end, the importance is not just for the physician, it is what is right for the patient. Patients will get the correct and best procedure for their particular anatomic and clinical situation. “In managing venous disease, one technique or one device never replaces everything else, but each one of them has a particular optimal use in treatment situations. Now the doctor can utilize the best solution and get paid for it. “So now its use will increase significantly because it now has a code for billing for those times when it is the best tool to use.” Dr. Elias described his first in man study of ClariVein. “We treated 30 patients using the ClariVein device. The results were just as good if not better than the existing devices that were out there, laser or radiofrequency. “Then we followed those patients for up to three years and the results are exactly the same as all of the existing technologies in that they improved patients’ quality of life and the surrogate outcome of closure rates. “It’s exciting because ClariVein was initially indicated for physicians to use in the vasculature. So a doctor could decide to use it in any blood vessel they want for whatever reason. “It was very, very good, but no one used it for anything except taking care of vein disease. And now its specific procedure code states that’s what it is for.” VT N
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PRODUCTNEWS significant advancement in therapy options for patients,” Professor Bruno Scheller of Saarlandes University Clinic in Homburg, Germany, said in a statement. VT N
AngioSculptX PTCA scoring balloon catheter
Drug-coated PTCA catheter gains CE Mark Spectranetics from Colorado Springs, Colo., won the CE Mark in Europe to bring to market its AngioSculptX drug-coated percutaneous transluminal coronary angioplasty (PTCA) scoring balloon catheter. Originally developed by AngioScore, a company purchased by Spectranetics, the device is a drug coated version of the company’s proven AngioSculpt PTCA scoring balloon catheter and is indicated for treatment of coronary artery stenosis, which includes in-stent restenosis. “AngiosculptX represents a unique coronary scoring technology that incorporates a drug coating. Given its clinical results, it is a
LimFlow gets CE for end-stage CLI venous treatment LimFlow SA announced Nov. 15 that it has received CE Mark approval for its fully percutaneous LimFlow System designed for venous arterialization of the lower limbs in end-stage patients at risk for limb amputation for critical limb ischemia (CLI). “Due to the ongoing epidemic of diabetes and cardiovascular disease, every year more and more patients are presenting with endstage CLI, and the tools we have to treat them are limited,” commented Steven Kum, MD, Vascular Surgeon at Changi Hospital in Singapore. “The LimFlow System is a new and critically important option for patients who suffer substantially from their ischemic foot. This therapy will create a strong foundation for us as vascular specialists, working with a wound care team, to provide new hope for them.”
Designed to promote chronic wound healing and avoid major amputation, the LimFlow System offers a new percutaneous therapy option for patients who have exhausted all other revascularization methods. The system works by proprietary ultrasound guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein in order to vascularize the entire ischemic foot. Both first-in-man and CE Mark clinical studies have been completed for the LimFlow System. Initial results have been presented at the Amputation Prevention Symposium and the Vascular International Advances Annual Conference. Journal publication of these results is expected soon. VT N READ MORE: limflow.com
Gore’s DrySeal Flex Introducer Sheath for EVAR procedures Spectranetics
Spectranetics gets CE Mark for small balloon Spectranetics picked up a CE mark for an even smaller iteration of its drug-coated angioplasty balloon. This one is designed to treat small vessels, below-the-knee peripheral artery disease (P.A.D.) and critical limb ischemia (CLI). The new 0.014” Stellarex balloon joins a 0.035” version, which earned the CE mark in 2014. The Stellarex technology is not licensed in the U.S. The balloon uses the company’s EnduraCoat tech to prevent drug loss while deploying the device and to enable controlled drug delivery at the treatment site. P.A.D. affects as many as 9 million people in the United States and is caused by the narrowing of blood vessels that limit blood flow to the limbs. People with P.A.D. may or may not experience symptoms, the most common of which is pain in the legs. CLI, which affects more than 3 million people in the United States and Europe, is characterized by severe blockage of the arteries that significantly restricts blood flow to the extremities. It can cause severe pain and skin ulcers. With the new Stellarex drug-coated balloon, Spectranetics hopes to improve outcomes for CLI patients by warding off restenosis, which frequently occurs within three to six months following treatment. Restenosis in CLI patients can lead to wounds not healing, the need for reintervention and amputation. “Spectranetics is committed to providing specialized and innovative tools and compelling clinical data to improve our patients’ quality of life,” said CEO Scott Drake in a statement.
“Stellarex 0.014” exemplifies these important elements and augments our existing product portfolio, which now includes clinically differentiated treatment for both above and below the knee disease. The Stellarex 0.014” DCB is a significant advancement in our effort to eradicate restenosis and amputation.” VT N
DrySeal Flex Intro Sheath W. L. Gore & Associates Inc. has announced the commercial availability of the GORE DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the United States, Europe, Canada and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures. The 12 Fr x 45cm sheath configuration is engineered specifically for use with the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE), the only device indicated in the country for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control. “Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery,” Marcus Brooks, consultant vascular surgeon from the North Bristol NHS Trust. “The IBE is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed. With the GORE DrySeal Flex Introducer Sheath, I now have a sheath specifically designed for GORE continued on page 31
DECEMBER 2016/JANUARY/2017 VEIN THERAPY NEWS
CALL FOR REGISTRATION REGISTRATION REGISTRATION OPEN OPEN ABSTRACTS NOW OPEN
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Abstract Submission Deadline Visit veinforum.org for2016 more info! September 21, http://www.veinforum.org
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VEIN THERAPY NEWS DECEMBER 2016/JANUARY/2017
30TH ANNUAL CONGRESS $&3FRQWLQXHVWRDGYDQFH YHQRXVHGXFDWLRQ By Mike Armitage The ACP celebrated three decades at the forefront of venous related education with the recently held Annual Congress, Nov. 3-6, 2016, at the Anaheim Marriott in Anaheim, Calif. This past November, the American College of Phlebology (ACP) hosted what has become the largest and most comprehensive meeting dedicated to venous and lymphatic disorders in the U.S. Under the direction of Program Co-Chairs Carl Black, MD, and Kathleen Gibson, MD, the scientific program set the standard with innovative and engaging content, respected faculty from around the world and opportunities for all levels of skill and knowledge. In addition, LE&RN spokesperson and Academy Award-Winning actress Kathy Bates addressed the conference on the “Human Cost of Lymphedema.” The impassioned talk provided a patient perspective on surviving and managing lymphedema after Bates had breast cancer and underwent a double mastectomy. The meeting remains the largest of its kind in the nation, drawing nearly 1,200 total attendees, including registrants, more than 100 faculty and 67 exhibiting companies and organizations. Program highlights included: luminary lectures given by leaders in vascular surgery,
Hands-on look at a new ultrasound
interventional radiology, and vascular medicine; hands-on workshops and small group lectures in non-thermal ablation, sclerotherapy, compression, and superficial venous imaging; in-depth sessions on lipedema, thrombophilia and unusual vascular disorders; and a “World of Phlebology” debate session which pitted the world’s experts on opposing sides of controversial issues. On Sunday, a comprehensive Practice Management symposium provided attendees with the skills to be more efficient and attract new patients. Along with the scientific sessions, the Annual Congress also presented sessions to help providers manage insurance challenges, understand the literature in venous disease, deal with ethical challenges and learn about credentialing and accreditation.
SPECIAL EVENTS The Annual Congress curriculum was challenging, but the mild southern California weather provided a relaxing backdrop for networking and engaging with colleagues. The 10th Annual ACPF Golf Outing kicked off the event on Wednesday with nearly 70 players, representing clinical vein care and industry, all with the goal of raising money for the ACP Foundation (ACPF). On Saturday, the Second Annual ACPF Fun Run & Walk saw more than 150 runners
Speaker, Kathy Bates participate in a friendly 5k dash around Disneyland. The Foundation also raised money through the Silent Auction, which was held on-site over the course of the three-day conference. Attendees could bid on more than 100 items, ranging from medical devices and services to vacations to sports memorabilia.
For those not at this historic meeting, the recorded content from all three and a half days will be available on the ACP’s Online Education Center in December at www.education.phlebology.org. And, be sure to mark your calendars for the 31st Annual Congress – Nov. 2-5, 2017, at the JW Marriott in Austin, Texas. VT N
Exhibit Hall kept vendors busy
DECEMBER 2016/JANUARY 2017 VEIN THERAPY NEWS
the premier association for vein care professionals. The American College of Phlebology (ACP) is comprised of more than 2,000 physicians and allied health care professionals, who are setting the pace and direction for growth in the field of vein care. The ACP offers members advocacy, continuing education and training in the latest procedures with the goal of improving standards and the quality of patient care. If you treat or have an interest in venous and lymphatic disease, the ACP is an unequivocal resource for your practice.
together we thrive continuing education latest news & information clinical guidelines
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VEIN THERAPY NEWS DECEMBER 2016/JANUARY/2017
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PRODUCTNEWS GORE continued from page 26
use with the IBE and flexible enough for easy access to the iliac branch vessels.” The new sheath leverages technology from Gore’s long-trusted GORE DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45 and 65cm. Jason T. Lee, MD, professor of surgery at Stanford School of Medicine said the availability of this new sheath provides more options to treat a broader range of patient anatomy. “The sheath supports my cases from
start to finish, offering confidence for a wider range of applications than ever before.” VT N READ MORE: goremedical.com/
Vein illuminator global sales to grow 32% by ‘25 A new Research and Markets report, “Global Vein Illuminator Market Analysis & Trends - Industry Forecast to 2025” predicts that the global vein illuminator market is poised to grow at a CAGR of around 31.8 percent over the next decade to reach approximately $510.3 million by 2025. This industry report analyzes the global markets for vein illuminator across all the
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given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2013, 2014 revenue estimations are presented for 2015 and forecasts from 2016 till 2025. The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments and future strategies. The report highlights include: • The report provides a detailed analysis on current and future market trends to identify the investment opportunities. • Market forecasts till 2025, using estimated market values as the base numbers. • Key market trends across the business segments, regions and countries. • Key developments and strategies observed in the market. • Market dynamics such as drivers, restraints, opportunities and other trends. • In-depth company profiles of key players and upcoming prominent players. • Growth prospects among the emerging nations through 2025. • Market opportunities and recommendations for new investments. Companies detailed in the report include: AccuVein Inc., Cambridge Medical (Asia) Private Ltd, Christie Medical Holdings Inc., Infrared Imaging Systems Inc., Near Infrared Imaging Inc., Sharn Anesthesia, TransLite LLC , Venoscope LLC, Vuetek Scientific, LLC. And ZD Medical Inc. VT N READ MORE: researchandmarkets.com / research/mjxqrd/global_vein
Congress sends 21st Century Cures Act to Obama A bipartisan, $6.3 billion bill that speeds up drug approvals, funds research in cancer and brain science, strengthens mental healthcare, and combats opioid abuse won overwhelming approval in the Senate Dec. 7. It now goes to President Barack Obama for his promised signature. The measure, dubbed the 21st Century Cures Act, passed the House of Representatives in late November in a 392 to 26 vote. The margin of victory in the Senate, 94 to 5, was just as overwhelming. Casting the “no” votes were Sen. Mike Lee (R-UT), Sen. Jeff Merkley (D-OR), Sen. Bernie Sanders (I-VT), Sen. Elizabeth Warren (D-MA), and Sen. Ron Wyden (D-OR). A broad swath of the healthcare industry supported the Cures bill. The bill was backed by the American Heart Association, other medical societies, the Arthritis Foundation, the Association of American Medical Colleges, and the Pharmaceutical Research
and Manufacturers of America, the trade group for drug makers. Most of the Cures money – $4.8 billion – goes to the National Institutes of Health (NIH) for research that includes the Cancer Moonshot, the Precision Medicine Initiative, the Brain Research through Advancing Innovative Neurotechnologies (BR AIN) Initiative, and regenerative medicine. Senate Republicans renamed the portion of the bill directing $1.8 billion to the Obama administration’s Cancer Moonshot and its quest for a cure after Beau Biden, the son of Vice President Joe Biden. Beau Biden died of brain cancer last year, and his father has led the Obama administration’s Moonshot initiative. The mental health provisions of the Cures bill fund suicide-prevention programs, mental health services for children, and programs for court-ordered outpatient treatment. It reinforces current laws that require insurers to treat mental illness as they do any other illness in terms of benefits. And it creates a new position in the U.S. Department of Health and Human Services called the Assistant Secretary for Mental Health and Substance Use for coordinating mental health programs across the federal government. The federal campaign to treat and prevent opioid abuse receives an infusion of $1 billion from the Cures bill. The beneficiaries are state programs that monitor drug prescribing, treat individuals addicted to prescription drugs, and train clinicians. The centerpiece of the 21st Century Cures Act is provisions that would speed up the development and approval of new drugs and medical devices by the U.S. Food and Drug Administration (FDA). The legislation puts less emphasis, for example, on randomized clinical trials in FDA reviews of new indications for a drug already on the market. Instead, the bill encourages the FDA to use “real-world evidence,” such as data from observational trials and insurance claims. The bill’s authors contend that in determining a product’s efficacy and safety, the FDA often doesn’t recognize valid sources of data generated by new technologies. The FDA needs to modernize its vetting process, they say, to enable manufacturers to keep pace with rivals in Asia and Europe. Public Citizen and the National Center for Health Research have issued “speed kills” warnings. Opponents, who have dubbed the bill the “21st Century Quackery Act,” argue that the measure will lower the regulatory bar, resulting in less safe and effective products reaching the market. VT N
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