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INSIDE Intact Vascular raises funds for trials IBM Watson can manage Big Data Do you have a plan for ICD-10? Where’s the ROI in ICD-10?

JUNE/JULY 2015 Vol. 8 No. 4 VEINTHERAPYNEWS.COM

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An ACP recognized resource for news and information for and about the phlebology community

ACP, VTN expand cooperative editorial, promotion agreement The American College of Phlebology and Vein Therapy News have extended a cooperative agreement to promote educational and timely editorial information to readers of Vein Therapy News (VTN). ACP has designated that VTN is “a recognized resource for news and information for and about the phlebology community.” In the 2014 agreement, VTN provided a section in each issue called ACP UPDATE. The American College of Phlebology (ACP) provided information to the venous treatment community for the section, and VTN provided advertising space for the ACP in three issues to promote any venous disease community programmatic event considered of interest. The 2015 agreement expands on the success of the 2014 agreement. The ACP UPDATE section will be enlarged to provide bylined counterpoint arguments to an issue of interest. VTN has increased the available space for ACP promotional advertising to a full page in each issue.

Pulmonary embolism intervention Dr. Charles B. Ross, with Dr. Robert Powers observing, is performing a pulmonary embolism intervention recently in lab 6 at the Piedmont Heart Institute. Please see the interview with Dr. Ross on page 22.

ACP, VTN

continued on page 12

FDA recalls Medtronic VenaSeal Closure System Medtronic’s VenaSeal Closure System, manufactured by Covidien LLC in the United States, has been recalled by the U.S. Food and Drug Administration because of a possible sterility breach of the outer packaging (pouch) material, which could compromise the outside surface sterility of the sealed inner tray. No units have been sold in the United States, but 1,661 units have been sold in 14 countries, including Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom. The U.S. launch was scheduled for midspring.

The FDA says it’s now under a Class II recall, reserved for situations in which “use of, or exposure to, a volative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The VenaSeal Closure System is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.

The device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it. VENASEAL

continued on page 11

CVC 2015 conference detailed The 5th annual Chicago EndoVascular Conference (CVC 2015), will get underway July 8 and continues through July 10 at the Swissotel Chicago, with the Pedal Artery Access Cadaver Course on July 11. CVC 21015 is a comprehensive arterial and venous endovascular conference. “Once a year, a group of impactful and motivated medical professionals dedicated

to the endovascular treatment of arterial and venous disease gather for the CVC experience,” Course Director Jaafer Golzar, MD, FACC, FSCAI, said. “CVC is a winning formula of worldrenowned faculty, dedicated attendees CVC 2015

continued on page 10

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Disclaimer and Liability Statement The information contained in this publication, including text, graphics and images, is for informational purposes only, and is not intended to be a substitute for professional medical advice. Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, accept no responsibility for any injury or damage to persons or property occasioned through the implementation of any ideas or use of any product described herein. In consideration that great care is taken by the Publisher, Editors, staff, and Editorial Board to ensure all information is accurate, we recommend each reader seek independent verification of all product or drug usage, surgical techniques and clinical processes prior to their use or implementation. The opinions expressed in this publication and all related marketing or sales material of this publication are those of the authors and are not attributable to the publication, Publisher, Editor, staff, Editorial Board, advertisers, or sponsors. References made in articles may indicate uses of medical equipment or medical procedures, or of drugs at dosages, for periods of time, and in combinations not included in the current prescribing information. Inclusion of advertising material in this publication, or in reproduction of articles and pages, or in supplemental materials, does not constitute any representation or guarantee by Publications & Communications LP (PCI), Publications and Communications LP, and Vein Therapy News, via its Editors, Publisher, Editorial Board members, or staff, of the quality of such products, or of the claims made by the manufacturers. Trademarks are used in an editorial fashion with no intent to infringe. Reproduction in whole or in part of this publication is strictly prohibited.

Reader Services SUBSCRIPTIONS To subscribe or to purchase back issues of the magazine, please call 800-678-9724 ext. 344 or e-mail Beth Chorba at bethc@pcinews.com. For more information, please visit www.veintherapynews.com and click on the Subscribe link. ADVERTISING INFORMATION If you are interested in advertising in Vein Therapy News magazine, online or in our Marketplace, please contact one of our account executives: Gary Pittman, Jr., 512-637-0373, garypjr@pcinews.com, or Dennis Carter, 512-637-0371, dennisc@pcinews.com. EDITORIAL SUBMISSIONS Doctors, nurses, clinics, managers, vendors, patients, professors and others are encouraged to submit abstracts, white papers, writings, and ideas for editorial consideration. If you have a paper or story idea to submit, please e-mail larrys@pcinews.com UPCOMING EVENTS AND PRESS RELEASES Vein Therapy News would like to hear about your organization’s upcoming event, product launch, or announcement. Please e-mail press releases or event listings at least two months in advance to larrys@pcinews.com

VEIN THERAPY NEWS < JUNE/JULY 2015

Volume 8, Number 3

Editor Larry Storer larrys@pcinews.com 254-399-6484

Art Director Lisa Gouveia lisag@pcinews.com

Advertising Executives Gary Pittman, Jr. 512-637-0373 garypjr@pcinews.com Dennis Carter 512-637-0371 dennisc@pcinews.com

Accounting Beth Chorba bethc@pcinews.com

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President Gary L. Pittman garyp@pcinews.com Publications & Communications, LP 13552 Highway 183 N, Suite A Austin, TX 78750 512-250-9023 • 512-331-3950 fax Vein Therapy News is published bimonthly by Publications & Communications, LP, Gary L. Pittman, President, 13552 Highway 183 N., Suite A, Austin, TX 78750 512-250-9023. Subscriptions are available for $45 per year. Payment must accompany orders. Copyright 2015 by Publications & Communications, LP. All rights reserved. Reproduction in any form without written consent from the publisher is strictly prohibited. Postmaster: Send changes to Vein Therapy News Circulation Department, 13552 Highway 183 N., Suite A, Austin, TX 78750. ADVERTISING 512-637-0373

NEWS 1 ACP, VTN expand pact The American College of Phlebology and Vein Therapy News have extended a 2014 cooperative agreement to promote educational and timely editorial information to readers of VTN. ACP has designated that VTN is “a recognized resource for news and information for and about the phlebology community.”

FDA recalls VenaSeal

Medtronic’s VenaSeal Closure System, manufactured by Covidien LLC in the United States, has been recalled by the FDA because of a possible sterility breach of the outer packaging (pouch) material, which could compromise the outside surface sterility of the sealed inner tray. Nonbe have been sold in the United States.

10 Dr. Bush sets CVC lecture Dr. Ron Bush will discuss his changed perception of the pathophysiology of cutaneous venous disease at the CVC 2015, July 8-10 in Chicago. He is a co-program show for the conference.

THE PRACTICE 18 HIPPA-compliant websites

In the busy world of healthcare, website functionality, design, maintenance, hosting, etc. often gets put on the backburner for the more urgent aspects of running the practice. That would be a mistake.

20 Relationship marketing errors

More and more marketing firms offer the concept of direct to referral physician marketing programs across the country. Unfortunately, some are offering bad advice, which can derail your practice.

21 What’s your tier?

New narrow networks and physician tiering is being implemented by payers across the nation. Are you aware of the extent to which tiering is taking place at payers, and should you be alarmed?

SECOND LOOK 22 Using UA-CDT for submassive PE

Charles B. Ross, MD, FACS, chief of vascular and endovascular services at Piedmont Heart Institute in Atlanta, sat down with Vein Therapy News to discuss current practice, challenges and opportunities in the management of pulmonary embolism, including his experience with ultrasound-accelerated, catheter-directed technology.

24 ICD-10, ready or not?

Unless Congress delays implementing ICD-10 again by requiring 18 months of testing or bans it outright, the deadline of Oct. 1 looms. What the ICD-9/ICD-10 debate means to children’s medicine and what nurses think about the debate is covered in a pair of articles.

CIRCULATION 512-637-0344 EDITORIAL 254-399-6484

WHY YOU SHOULD ADVERTISE IN VEIN THERAPY NEWS ACP ENDORSES VEIN THERAPY NEWS

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Maisel, M neited .4 92cent) e first in edleSta rt minim stites Sdu of the O ck s.for treatm wereper D, MPH pe is not app al-to rovedhuinman ffice re. , ent tiv ico rcent at 12 o sbrpu for-nthi and 24 thetria l uirpo Center fo of Device Evalu acting director singse for ma respofecvar agents ely.se veins but has results in m on at r bee ny • io th D yea n n Res rs. perton evices an used s, in the FD a wide range sa id the dA from ic ine can the D d Radi A’s of veins, and ults Hy formation TA VenaSeal C loitsuisrenot use the sal Eu peannot treat 4 millimeters.4 system m ologica l Hea lth, tem, and hem ck ica in veiro l abl Hy pertonPric Syful ust Mor ns wider Sa ph ation st em differs fro rison salct ospe ine atment due to m proced be used as a sysis (e O bs er vatha neon of Mtre la ser, radi alsSC iv o E not Scottsdale orris wid the ur ely used asti on pain, o waves or es in buth , Ariz., th rnie ngJoand leg OPE) stu a al inren Agon entsVe remove ve cuts in th that use drugs, um cur e natio gatoby ur nal cra publish r ofden ondy ins. e sk in to inject of mp theatu prin- tly useddeinmthe ion. ed varicona Vas scu VeronstrUn close or sel vei lar Su ncl Sta ateitedcu ns te mudise an sodiumClose Tria l, sa treatm rger y mtes ulatfor id the include sodium tetradaecy ent of adva nced and glycer iv e clo in l sulfate, polid sure rate (commonly com at deliver varicose oca nol of s results vein pounded wit salm that are h ine nt epi nep hri et,howh ich compane). ds continue V E NA SE A L d on pa CH EM ICAL ge 23 AB More th continued LATIONS an on 70 page 32 0 at tend the world ee s from al al Intern are expected fo l over r ationa l ea se. 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NEWS Saphena Medical raises half of $3 million in new funds Saphena Medical, which is developing a device to harvest veins for coronary artery bypass grafting, is almost halfway toward raising $3 million in new funding. At the end of March, Saphena reported raising close to half of a $3 million planned offering toward development of a device designed to harvest veins for coronary artery bypass grafting. The West Bridgewater, Mass.-based startup disclosed in a recent SEC filing that it has pulled in nearly $1.27 million so far, through the sale of Series B preferred stock. Saphena hopes to raise $3 million, according to the filing.

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Co-founders Pavilion Medical Innovations and STD Med announced in February 2014 that the startup had secured $3 million in Series A funding designed to take Saphena’s OnePass endoscopic vein harvesting platform through regulatory clearance. OnePass gained the FDA’s 510(k) clearance in late July. Pavilion, a Norwell, Mass.-based developer of medical technology companies, announced Saphena’s 2014 launch and initial fundraising. Pavilion founder Michael Glennon is Saphena’s president. Co-founder STD Med is an original equipment manufacturer based in West Bridgewater. VT N

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InterVene trial to study correcting CVI with minimal invasive catheter InterVene Inc. has raised $5.9 million in Series A funding to support a two-stage clinical trial, according to CEO Fletcher Wilson. “These studies will be the first ever involving a catheter-based therapy to correct the underlying cause of chronic venous insufficiency (CVI) by creating new deep vein valves out of a patient’s own vein wall tissue,” Wilson said. The trials will be aimed at demonstrating clinical functionality and acute safety. CVI affects up to 24 percent of adults and results in painful venous ulcers that cost the U.S. healthcare system nearly $2 billion annually. In a significant percentage of cases, the condition involves faulty deep vein valves in the legs which cause blood to flow backwards to the feet, triggering an inflammatory cascade, skin changes and ulceration. Currently available treatments for deep vein CVI are limited to palliative therapies such as compression stockings and wound care. InterVene’s minimally invasive approach creates venous leaflets from the intima – the innermost layer of the vein wall – while leaving the outermost layers intact. These leaflets function as one-way valves, restoring normal venous pressure and preventing blood from pooling in the legs. This percutaneous technique is predicated on The Maleti Neovalve, an open-surgical procedure. Anthony Comerota, MD, vascular surgeon and director of the Jobst Vascular Center at Toledo Hospital, said InterVene’s device could transform the open-surgical neovalve procedure to a percutaneous procedure. “Few surgeons have mastered the surgical neovalve procedure,” Dr. Comerota said. “Therefore, many more patients may benefit from this reconstructive technique.” InterVene arose out of the Stanford Biodesign Fellowship, before joining The Fogarty Institute for Innovation, which was instrumental in the company’s development. The company is currently moving to a new facility in Silicon Valley. InterVene has developed the first nonimplantable, catheter-based, vein valve creation therapy. The product is designed to treat chronic venous insufficiency (CVI) in the deep veins – a severely under-treated disease that causes painful venous stasis ulcers and other debilitating symptoms in millions of Americans annually. VT N READ MORE: intervene-med.com

CEO Erin Gibbs

AVVI company named to top women-owned Colorado firms American Vein & Vascular Institute, a network of vein and arterial disease diagnosis and treatment centers in Colorado and Texas, announces that the practice management side of its business, owned by CEO Erin Gibbs, has been named to ColoradoBIZ Magazine’s 2015 Top 100 Woman-Owned Companies List. Operating under the American Vein & Vascular Institute umbrella, the practice management and business development branch of the company functions to serve the clinics from a business operational standpoint and specializes in managing finance, marketing, technology and special projects. The management team develops and executes strategic processes and procedures for the operational success of the business as a whole. Each year ColoradoBIZ Magazine honors companies owned by women throughout the state of Colorado, spanning across sectors ranging from marketing to aerospace, with their Top 100 Woman-Owned Companies list. Companies are chosen based on their revenue, and the women visionaries who lead them are recognized for their accomplishments in the print edition of the magazine, online and in person at a special reception and awards show. This year’s reception was June 17 in Denver. “It is a huge honor to be selected to ColoradoBIZ’s Top 100 WomanOwned Companies list,” Gibbs said. “I am proud of the growth the American Vein & Vascular Institute has made, and thrilled that we are being honored for our achievements, especially with so many women in positions of leadership in our company and within the state of Colorado. This is our home, and I couldn’t be more grateful for the opportunities it has given us. I look forward to attending the reception in June, and being among exceptional company.” VT N

JUNE/JULY 2015 < VEIN THERAPY NEWS

NEWS

Surgeon gets more funds for needle puncture-resistant gloves A doctor at Rutgers Robert Wood Johnson Medical School has secured funding to develop puncture-resistant surgical gloves for professional healthcare use. As part of its Innovation Stage Funding Program, New Jersey Health Foundation has awarded a second grant to Tomer Davidov, MD, and assistant professor of surgery at Rutgers. Laura Fabris, assistant professor in the department of materials science and engineering at the Rutgers school of engineering, where she has done significant work with nanoparticles, will collaborate with Dr. Davidov, using the $20,000 in grants to advance the project. “We became interested in working with Davidov and Fabris because needle-sticks

among healthcare professionals present a significant problem,” explained George F Heinrich, MD, vice chair and CEO of New Jersey Health Foundation. “According to a recent survey, 99 percent of all surgeons have admitted experiencing needle-stick injuries during his or her lifetime,” Dr. Heinrich added. Drs. Davidov and Fabris are working to radically improve the mechanical properties of a glove that could retain its flexibility and smooth texture, offering healthcare professionals the highest level of needle-stick protection without compromising tactile sensation and manual dexterity. “Healthcare workers worldwide are at high risk to contract viruses such as hepatitis C and HIV due to inadequate protection provided

by surgical gloves that are currently commercially available,” Dr. Davidov said. “While many types of gloves have been tested, there are none currently on the market that are puncture resistant yet flexible enough to provide surgeons with the dexterity they need during surgical procedures.” Through the Innovation Stage Funding Program, New Jersey Health Foundation provides grants to researchers with promising ideas to advance an intellectual property toward commercialization. “New Jersey Health Foundation is delighted to support researchers with promising ideas that could open doors for new, innovative technology,” said James M Golubieski, president of New Jersey Health Foundation. “We are particularly excited about the new

technology being developed by Dr. Davidov and Dr. Fabris as it has terrific potential to improve safety conditions for surgeons and other healthcare professionals at risk due to needle-sticks.” VT N

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VTNREPORT AUTHOR’S BIO INFO CORRECTED On page 26 of the April/May issue of Vein Therapy News, Dr. Manu Aggarwal shared a case study regarding treatment of swollen and discolored legs where a patient failed to disclose all mediations, in particular minocycline. Elements of Dr. Aggarwal’s biography were out-of-date. Here is the correct bio information: Dr. Manu Aggarwal, MHSA, MD, is a board certified family physician and medical director specializing in phlebology at the Vein Care Center. Since 2007, the VCC has been an IAC-accredited vascular laboratory. The VCC has been dedicated to venous disease and laser treatments since 2004. It is located in Lima, Ohio, with a satellite office in Celina, Ohio. Vein Therapy News regrets using outdated bio information from the website.

VASCULAR PATHWAYS, NOVATION SIGN PACT Vascular Pathways has entered into a three-year contract with Novation to distribute its AccuCath line of catheters, the Boca Raton, Fla., company announced. A healthcare services company, Novation is headquartered in Irving, Texas The intravascular catheters feature a coiled tip Nitinol guidewire, blood control valve and needlestick safety options. The product’s design is intended to increase first-time success, reduce complication rates, extend dwell times, increase patient satisfaction and lower overall provider costs, according to the devicemaker.

MEDNAX ACQUIRES VIRTUAL RADIOLOGIC Teleradiology provider Virtual Radiologic (vRad) has been acquired by national medical group Mednax for $500 million. The vRad current management joined Mednax as part of the acquisition, which closed May 19. The company’s headquarters, operations and client support center will remain based in Eden Prairie, Minn. Virtual Radiologic has more 350 U.S. board-certified and eligible physicians, 75 percent of whom are subspecialty trained, interpreting more than 5 million patient studies annually for more than 2,100 client hospital, health system, and radiology group facilities, according to the company. Virtual Radiologic was one of the early teleradiology providers, and has grown over the years through a series of acquisitions. However, as the firm grew, it also faced a number of competitive pressures, including aggressive price competition and pushback from radiologists who increasingly began to see the firm as a competitor. The company was taken private in mid-2010 by equity firm Providence Equity Partners, which bought the company for $294 million.

CONGRESSMAN PAULSEN PREDICTS DEVICE TAX REPEAL Minnesota Congressman Erik Paulsen predicts a bill repealing the medical device tax will be passed – soon. “I think we’re going to see that get across the finish line at some point this year,” he said, speaking at a May MedTech Investor Conference in Minneapolis. Paulsen said a Ways and Means committee was held June 2 to figure out the best timing to launch a new bill – as well as the best opportunity to get it through the House. This could involve packaging the bill with something else, Paulsen said, so as to push it through Senate as well. “Timing is everything – so we want to make sure we do this correctly,” he said. Paulsen said that pushing a repeal for the medical device tax is his “key passion right now.” Indeed, he’s one of the industry’s most avid advocates in terms of repealing the controversial excise tax – a 2.3 percent levy on revenues from medical device sales. This effort has already generated bipartisan support. The House has already voted twice in favor of a repeal of this Obamacare mainstay; Senate has yet to formalize its support but seems generally receptive to a repeal.

SMITH & NEPHEW GETS WARNING LETTER Smith & Nephew has received a FDA warning letter for quality-control violations at its Andover, Mass., facility related to problems with some of the company’s mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints. The Truclear Ultra Reciprocating Morcellator 4.0 is a disposable blade that attaches to the Truclear Hysteroscope 8.0. Among the violations are a “failure to establish and maintain procedures for verifying or validating corrective and preventive actions” following complaints of loss of visualization when using the Truclear Ultra Reciprocating Morcellator 4.0.

Bush outlines CVC lecture By Ron Bush, MD As a vascular surgeon for the last 20 years, I have focused only in the treatment of venous disease. In those 20 years, 70 percent of the patients presented with spider telangiectasias, facial veins or hand veins. The key to a successful venous practice is to treat superficial visible veins located above or below the dermis. Figure 1 illustrates a superficial pathologic spider vein. The target of the intended therapy lies 300 to 700 microns below the skin surface. Only by histological examination can we know the effectiveness and potential damage of any treatment. The last two years working at Water’s Edge Dermatology has allowed me to utilize resources that have changed my perception of the pathophysiology of cutaneous venous disease. The large patient base has enabled me to see and treat not only superficial pathology on the legs, but veins in all locations. Using the dermpath lab has allowed me to determine the correct concentration of sclerosant solutions, and in 80 percent of CVC 2015

continued from page 1

and CVC is a winning formula of worldrenowned faculty, dedicated attendees and ground-breaking content in an immersive and focused atmosphere.” He said CVC is a purely vascular conference with no coronary intervention, no TAVR, no structural heart. Attendees can choose from simultaneous arterial and venous programs covering all aspects of endovascular medicine. The format is fast-paced talks, live cases, opportunities to learn about new and emerging technologies, live venous ultrasound demonstrations and CVC’s unique, ultrasound-guided pedal artery access cadaver course. International attendees and faculty from different fields can draw inspiration from one another. Attendees will gain hands-on experience with ultrasound guided access of the pedal arteries using cadaver legs on July 11. The fluid injected cadaver legs have been specifically prepared for CVC 2015 and Dr. Golzar said they provide a unique opportunity for attendees to hone and perfect The FDA said the company’s corrective action report about the problem contained insufficient information to prove that the issue had been resolved, and said the company continues to receive complaints about the problem even though the issue was first raised

Spider vein under the microscope our patients’ only one treatment is needed utilizing a technique that unloads the cutaneous venous hypertension. Most conferences that I have attended or been associated with contain a small amount of content on the topic of cutaneous pathology. However, most patients you see in your practice present with this very complaint. As program committee co-chair of CVC 2015 in Chicago, July 8-10, I have incorporated the aforementioned topics and other practical information into the agenda. My goal is to provide information that will help in the physician’s everyday practice. VT N

their technique for ultrasound guided pedal artery access. Nationally renowned faculty with expertise in pedal artery access will be present to help attendees during these sessions. Program Committee Chairs are Patricia Thorpe, MD, who specializes in venous disease at the Arizona Heart Hospital; and Jondelle Jenkins, DPM, who specializes in podiatry and advanced wound care at South Chicago Foot and Ankle Clinic. Co-chairs include Ron Bush, MD, who will lead the discussion on new and emerging venous therapies; Romi Chopra, MD, superficial venous disease; Jon George, MD, deep venous disease; Samer Abbas, MD, atherectomy; Miguel Montero-Baker, MD, complex aortic disease; Sonya Noor, MD, vascular surgery; and John Winscott, MD, critical limb ischemia and limb salvage. An exhibit hall will allow vendors and sponsors to highlight products to an international audience of phlebologists, VS, IC, IR, and podiatrists. VT N To register, see cvcpvd.com/ registration.html

in September 2012. The letter also says that S&N removed a prior hold on the morcellator in 2012 before completing its review of the complaints, in violation of the company’s own policy. VT N

JUNE/JULY 2015 < VEIN THERAPY NEWS

NEWS VENASEAL

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“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, MD, MPH and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.” The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical devices. Data

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supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs. The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute wholebody infection. Adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.

The VenaSeal system The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, N.C. Covidien was notified April 28, and the notice was posted May 12. VT N

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NEWS Yost: ‘Understanding Business of Peripheral Interventions’ Mary L. Yost, president of The Sage Group, lectured at the New Cardiovascular Horizons (NCVH) Inaugural Economic Session at the 16th annual NCVH meeting in May. Her lecture was titled “Understanding the Business of Peripheral Interventions. “The program of ‘The Business of Peripheral Interventions’ was structured to provide a comprehensive review of the current economic, financial and reimbursement issues surrounding peripheral and venous disease,” Yost said. “In contrast to coronary disease, little research has been published on costs and ACP, VTN

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The most recent edition of VTN at the time of the annual Congress will be included in the American College of Phlebology Foundation “bag drop” for attendees. Phlebology is one of the fastest growing segments within the medical community, according to Bruce Sanders, CAE and ACP executive director. “Keeping informed of the latest news and information both nationally and around the world is an essential part of advancing both the specialty and the individual members within it. “We would like to recognize Vein Therapy News for its engaging educational content and timely, relevant updates from within the world of phlebology,” he said. “Its coverage of current research, technology, procedures and practice management, as well as case studies, physician profiles, and news and new products makes VTN a valuable source of information for both physicians and industry professionals. “The American College of Phlebology and the American College of Phlebology Foundation maintain that VTN is a recognized resource for news and information for and about the Phlebology community.” Publications & Communications LP is publisher of the 8-year-old Vein Therapy News. President Gary Pittman praised the new agreement. “We’re excited about the expansion of this agreement and the increased cooperation between the publication and the ACP,” Pittman said. “The ACP provides its members tremendous educational resources, and we’re pleased to be a part of those resources. “For years we have brought an eclectic editorial product to our readers, which has resulted in a growing and interactive readership base. We have always wanted to bring as many viewpoints as possible to all editorial issues, and the expansion of the ACP UPDATE will certainly provide a compelling, thoughtful look at all sides of pertinent medical issues.” VT N

the economic impact of PAD and CLI or on the costs and consequences of the different treatment options. There is a significant unmet need for additional information and more research on all economic aspects of PAD. This meeting represents an important first step,” she said. According to The Sage Group, P.A.D. is one of the most widespread chronic diseases. Currently afflicting almost 20 million U.S. citizens, P.A.D. prevalence is exceeded only by diabetes and venous disease. Costing an estimated $200 to almost $400 billion, P.A.D. direct disease costs exceed those of diabetes and coronary disease, well as all cancers combined. “Despite the magnitude of the national bill, P.A.D. remains underestimated, underdiagnosed, undertreated and underresearched, which results in unnecessary mortality, morbidity and amputations,” Yost emphasized. “Because P.A.D. is so prevalent and costly, physicians, hospital administrators, insurance companies and Medicare/Medicaid policy makers need to understand its significant macroeconomic impact, the relative costs and consequences of different treatment options (including amputation), as well as the costs and consequences of not diagnosing and treating the disease,” Yost said. VT N READ MORE: thesagegroup.us.

Pleasing patients effort still elusive A new report from the American Consumer Satisfaction Index (ACSI) finds that overall patient satisfaction has dropped since 2014. But consumers were more satisfied with ambulatory care than the quality of care hospitals provide. The ACSI uses data culled from the more than 70,000 consumer interviews it conducts annually to score industries on a scale of 0 to 100. The healthcare sector overall scored a 75.1 in 2015, a 3.2 percent decrease from its 2014 score, which means patient satisfaction is at its “lowest level in nearly a decade,” according to the report. But while customer satisfaction may be down, demand for healthcare services rose nearly 6 percent in 2014, the report states, which would be the largest increase since the start of the recession. Though the trends of lower satisfaction and higher demand may seem to be at odds, one actually informs the other, ACSI Managing Director David VanAmburg said in a press release. READ MORE: theacsi.org/newsa n d - r e s o u r c e s /p r e s s - r e l e a s e s / press-2015/press-release-utilitiesshipping-and-health-care-2015

Senate health working group to take on improving EHRs Senate health committee chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.) say that a new bipartisan committee’s working group will gather on Capitol Hill throughout the coming months to find ways to improve electronic health records (EHRs). The group will work to find five or six ways to “make the failed promise of electronic health records something that physicians and providers look forward to instead of something they endure,” Sen. Murray said in an April 29 press release. While adoption of EHRs has grown, many physicians aren’t satisfied with the technology. In a recent survey by Accenture of 600 U.S. physicians, only 46 percent believe EHRs improve treatment decisions and 64 percent believe they reduce medical errors. “After $28 billion in taxpayer dollars spent subsidizing electronic health records, doctors don’t like these electronic medical record systems and say they disrupt workflow, interrupt the doctor-patient relationship and haven’t been worth the effort,” “As we focus on making our health care system work better for families, electronic health records could not be more

important,” Sen. Murray said. “Having more and better information can make all the difference for patients, so I look forward to working with Chairman Alexander and members of our Committee to strengthen our nation’s health IT infrastructure and improve quality of care and patient safety in Washington state and across the country.” All members of the Senate health committee are invited to be a part of the working group. Staff meetings began immediately after the announcement, with participation from health IT professionals, industry experts and government agencies. The working group’s goals include the following: • Help providers improve quality of care and patient safety. • Facilitate interoperability between EHR vendors. • Empower patients to engage in their own care through access to their health data. • Protect privacy and security of health information. READ MORE: h elp.sen ate.go v/ne w s r oom / press/release/?id=b2707b16 2fb0-410f-aded-84d1a86357a2& groups=Chair

Nurses ambivalent on EHRs While nurses find electronic health records (HERs) help improve patient safety and make it easier to access health information, they say the systems often are inefficient and hurt outside collaboration, according to a recent study. HIMSS Analytics surveyed 600 nurses about their use of EHRs and opinions on the systems. The report was published on behalf of EHR vendor Allscripts. The nurses surveyed praised EHRs for helping improve safety (73 percent) and for enhancing collaboration within their organization (73 percent). They were dissatisfied, however, with the ability to collaborate with outside facilities, and also felt the tools affected how much time they could spend with their patients. Only 31 percent said they found EHRs enabled more time with patients. Nurses aren’t the only ones in the industry who feel this way. In a recent survey by Accenture of 600 U.S. physicians, 70 percent said EHRs decrease their time with patients. However, a majority of the nurses responding to the Allscripts survey did

not want to go back to paper records, despite their complaints. Just 15 percent said they would return to paper if given the opportunity. Nurses have been unhappy with EHRs for a while, though their responses to the Allscripts survey are not as severe as ones to a similar survey conducted last fall by Black Book Market Research. That report found of the 13,650 U.S. nurses responding, 92 percent were dissatisfied with in-patient EHRs. One way to ensure nurses are satisfied with EHRs is to bring them to the table when it comes to the EHR-purchasing process, Kerry Bruning, a pediatric oncology nurse and director of marketing for the Allscripts Sunrise organization, said in the report. “Being disengaged during the selection process, not feeling you were part of it, affects adoption,” she said. Sixty-six percent of the respondents said they had not been invited to be part of that process. VT N

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NEWS ONC releases privacy guide

security regulations in place help support interoperability, Lucia Savage, ONC’s chief privacy officer, writes at the agency’s Health IT Buzz Blog.

A new version of its privacy and security guide to help healthcare providers better understand how to integrate the requirements into their practices has been released by the Office of the National Coordinator for Health IT. “The Guide to Privacy and Security of Electronic Health Information” has new information on Medicare and Medicaid electronic health record incentive programs and on HIPAA Privacy, Security and Breach Notification Rules. The guide is the first step toward fulfilling the commitment made by the ONC in its Interoperability Roadmap to foster better understanding in the industry of how

Concerns of security and privacy in the industry are already growing, especially in the wake of large hacks so far this year on health payers Anthem and Premera. The ONC guide was last published in 2011, Savage says; the new version reflects the changes healthcare has gone through since then. Some of the areas the report covers include: Business associates. The report explains who a business associate is and in what ways it must comply with HIPAA regulations. This reflects changes made under the Health and Human Services Department›s omnibus rule, which makes contractors, subcontractors and other business associates of healthcare entities that process health insurance claims liable for the protection of private patient information.

HIPPA Privacy Rule. The ONC gives examples of how this regulation applies to a practice, and the rules surrounding use and disclosure of private health information. Meaningful Use. While the first guide focused on Stage 1 privacy and security objectives, this updated version also adds in core objectives for the second stage of the program. It does not yet address Stage 3. Security management. The report outlines a seven-step approach for providers looking to create a security management process. Steps include selecting a team; documenting the process, findings and actions; and developing an action plan. VT N READ MORE: healthit.gov/sites/ default/files/pdf/privacy/privacyand-security-guide.pdf

http://www.apsbilling.com aj@apsbilling.com

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NEWS Intact Vascular raises capital to finance trials Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, has raised $38.9 million in a Series B venture capital financing. The funds will be used to accelerate the development and FDA approval of the company’s Tack Endovascular System. Related to the financing, Intact Vascular also announced that NEA Partner Justin Klein, MD, JD, has joined the company’s Board of Directors. “We are poised to build significant value with the conduct of multiple clinical trials, both above and below the knee, all of which are aimed at demonstrating the unique value of the Tack Endovascular System in the treatment of peripheral artery disease and moving us through the FDA approval process,” said Bruce Shook, Intact Vascular’s president and CEO. “Intact Vascular’s approach to peripheral artery disease (P.A.D.) is truly novel and has the potential to significantly improve treatment of this rapidly growing disease,” Dr. Klein said. “We are excited to partner with the outstanding team at Intact Vascular and their investors to move rapidly into pivotal clinical trial work in peripheral artery disease and to explore new applications of this novel approach to vascular repair.” Intact Vascular was founded in 2012 to develop the technology pioneered by Peter Schneider, MD and director of the Division of Vascular Therapy at the Kaiser Foundation Hospital in Honolulu. Dr. Schneider envisioned a new, endovascular method for repairing arterial dissections following percutaneous transluminal angioplasty (“PTA”) to permit highly targeted repair of diseased arteries, while minimizing the metal left behind and inflammation of the artery wall, both of which are significant problems associated with stenting, the current method of dissection repair. Intact Vascular’s Tack Endovascular System is the realization of Dr. Schneider’s vision. Over the last three years, Intact Vascular has developed and refined the Tack Endovascular System implant and delivery system, conducted three international clinical trials, and obtained a CE-Mark for the above the knee system. The clinical trials enrolled more than 170 patients and demonstrated the promise of this new approach to arterial dissection repair. P.A.D.affects more than 200 million people worldwide and more than 19 million people in the U.S. The prevalence of peripheral artery disease among American adults exceeds that of coronary heart disease and its growth is being driven by the triad of obesity, diabetes and advancing age. VT N READ MORE: intactvascular.com

FDA lifts ban on blood from gay men if sexually inactive for year The U.S. Food and Drug Administration has formally proposed to end a 32-year-old ban on blood donations from men who have sex with men (MSM), provided they haven’t had such sex in the previous 12 months. The agency announced last December that it intended to issue this proposal in 2015. Last year, two separate federal advisory committees recommended this one-year deferral policy as safe, based partly on the experience of the United Kingdom, Sweden, Japan, Australia and other countries that already had adopted it. In 1983, shortly after the onset of the AIDS epidemic, the FDA advised blood centers not to accept donations from MSM for fear of contaminating the blood supply. Two years later, the agency revised the policy to turn away MSM blood donors if they had sex even one time with another man since 1977. Since then, groups in the lesbian-gaybisexual-transgender (LGBT) community have called the lifetime ban on MSM blood donors discriminatory while the American Medical Association (AMA) and the Red Cross have said there is no scientific basis for it. AMA President Robert Wah, MD, commended the FDA for changing course. “The AMA’s policy supports using scientifically-based deferral periods that are consistently and fairly applied to donors based on their risk level,” AMA Dr. Wah, stated in a news release. However, some LGBT advocacy groups such as GLMA, formerly known as the Gay and Lesbian Medical Association, object to the requirement that MSM must be sexually abstinent 12 months prior to donating blood. “While it’s encouraging to see some movement after 30 years of an unsound policy, GLMA continues to believe that the policy changes could have gone much further,” GLMA executive director Hector Vargas told Medscape Medical News. “What we have advocated for is a policy that focuses on individual risk rather than deferrals or exclusions based on categories or groups of individuals such as MSM. While there may be some MSM who may be able to donate based on the new policy, the practical effect of the one-year deferral is not much different from a life-time deferral, and it continues to stigmatize gay and bisexual men.” The proposed FDA guidance to blood centers was officially published in the Federal Register on May 15. The agency then will accept public comment for 60 days before issuing a final version of the recommendations

READ MORE: fda.gov/downloads/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/Blood/ UCM446580.pdf

NetScout joins health IT collaboration at HIMSS center NetScout Systems Inc. has joined the HIMSS Innovation Center in Cleveland, Ohio, as a new industry-level collaborator demonstrating its value to health IT professionals. The first of its kind, this year-round facility fosters collaborative testing and demonstration of how state-of-the-art interoperable systems improve the quality and efficiency of care for patients and communities. NetScout Vice President Tom Raimondi Jr., said the HIMSS Innovation Center is the only location in the world where vendors can validate – with other industry vendors – how their health IT solutions simply and seamlessly integrate and operate with emerging technology. “Leveraging the patented Adaptive Service Intelligence™ (ASI) technology and the advanced analytics of network traffic data provided by the nGeniusONE® Service Assurance solution, NetScout is helping healthcare organizations to manage, monitor and triage mission critical applications and services including Electronic Medical Records (EMR) and Picture Archiving and Communications services (PACs),” he said. The HIMSS Innovation Center is a permanent exhibition of interoperability where healthcare providers, payers and consumers can demonstrate secure exchange of patient health information. As an industrylevel collaborator, NetScout joins a team of innovators collaborating and facilitating health information exchange, working together to lead the advancement of health information management by optimizing the use of technology. The NetScout mission is to ensure the delivery of exceptional services and is teamed with the highest caliber of healthcare IT professionals in the market. Visitors to the HIMSS Innovation Center can take part in an interactive learning experience where they can simulate clinical scenarios about how health information technologies can improve patient care. HIMSS North America Vice President Joyce Sensmeier, MS, RN-BC, CPHIMS, FHIMSS, FAAN, said the HIMSS Innovation Center brings together industry organizations that understand and advance the value of health IT through their respective products and services. VT N

Medical students fail to learn how to work on a team Though new models of healthcare delivery increasingly focus on collaboration, medical education still does not adequately teach aspiring doctors how to work effectively with a team of caregivers, according to a post by Dhruv Khullar, MD, for the New York Times’ Well blog. Until they start residency, medical students neither study nor work with nurses, physician assistants, social workers or other non-physician professionals, according to Dr. Khullar, who is a resident at Massachusetts General Hospital and Harvard Medical School. Young doctors also aren’t taught how to understand their fellow clinicians’ roles and limitations. This isolated approach to medical education no longer makes sense given the industry’s accelerated shift toward value-based payment models that encourage team-based care, Khullar argues, adding that this is especially true in light of the Department of Health and Human Services’ announcement that it will shift 30 percent of Medicare payments to alternative payment models by 2018. A recent report from the Institute of Medicine reported by FierceHealthcare echoes Khullar’s concerns, as it found that there currently are no learning models that factor in all of the features necessary to measure the link between health outcomes and interprofessional education. Some notable exceptions to the paucity of team-based learning, however, include the National Center for Interprofessional Practice and Education, backed in part by the Robert Wood Johnson Foundation, and the Retooling for Quality and Safety initiative, led by the Josiah Macy Jr. Foundation and Institute for Healthcare Improvement. The latter awards grants to universities to support patient-safety focused interprofessional learning models, according to the post. Dr. Khullar said that initiatives such as these not only are more important than ever in an era of value-based care, but it’s also key to start such interprofessional training as early as possible and to focus especially on doctors, who research suggests need the most help learning how to collaborate effectively. “Team-based care forms the foundation of novel payment models and a higher-value health care system-and the training of new health professionals must reflect the evolving practice environment in which they find themselves,” he writes. VT N

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NEWS New CDO study results bring hope EO2 Concepts, an advanced wound-care technology company, has published interim study results on a new treatment approach that could lead to more effective and less expensive treatment of chronic wounds suffered by millions of diabetics. The study, a prospective, randomized, multi-center, double-blind clinical trial, suggests encouraging trends for patients receiving Continuous Diffusion of Oxygen (CDO) therapy, both in compatibility or superiority to existing CMS-covered therapies and, in particular, for slower-to-close, larger, chronic wounds. The absolute performance of 53 percent of patients receiving CDO therapy experiencing complete wound closure in 12 weeks compares very favorably to published results from other CMS covered therapies (30â&#x20AC;&#x201C;52 percent). In a series of exploratory analyses, significant and beneficial effects were found compared to patients who did not receive CDO therapy. The data, published in Wound Medicine, suggest that the more CDO therapy is needed (larger, more chronic wounds), the better it works. In this ongoing study, EO2 Concepts is using its TransCu O2 tissue oxygenation device to provide oxygen inside moist wound therapy dressings to the wounds of half of the study participants. The other half of the study group also received a TransCu O2 device with moist wound therapy dressings, but no oxygen. The TransCu O2 is a small, simple, easy-to-use oxygen delivery system that is portable and allows for constant treatment without limiting mobility. Its ability to provide a continuous, roundthe-clock supply of low-flow pure oxygen can treat a variety of lower limb wound types such as venous leg ulcers, diabetic foot ulcers and pressure ulcers. While oxygen-based therapies are proven effective in treating chronic wounds, the therapeutic approach to allow for 24-hour delivery of diffused oxygen is relatively new. CDO therapy works by diffusing oxygen directly into a moist wound, providing an optimized environment for the healing process. CDO therapy has been shown to improve healing time and success rates for foot, venous and pressure ulcers, skin grafts and burns, while significantly reducing costs compared to other therapies. VT N READ MORE: eo2.com

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THEPRACTICE

WATSON HEALTH UNIT IBM platform brings expertise to manage Big Data To dramatically advance the quality and effectiveness of personal healthcare, IBM) is establishing a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions. The HIPAA-enabled Watson Health Cloud will enable secure access to individualized insights and a more complete picture of the many factors that can affect people’s health. Extending the company’s exclusive Watson cognitive computing platform, IBM is: Entering new partnerships with leading companies, including Apple, Johnson & Johnson and Medtronic, to help optimize consumer and medical devices for data collection, analysis and feedback. Acquiring Explorys and Phytel to advance its healthcare analytics capabilities. Establishing a dedicated business unit – IBM Watson Health, to be headquartered in the Boston area. The future of health is all about the individual. With the increasing prevalence of personal fitness trackers, connected medical devices, implantables and other sensors that collect real-time information, the average person is likely to generate more than one million gigabytes of health-related data in their lifetime (the equivalent of more than 300 million books). However, it is difficult to connect these dynamic and constantly growing pools of information with more traditional sources such as doctor-created medical records, clinical research and individual genomes – data sets that are fragmented and not easily shared. A highly scalable and secure global information platform is essential to pull out individualized insights to help people and providers make timely, evidence-based decisions about health-related issues. “All this data can be overwhelming for providers and patients alike, but it also presents an unprecedented opportunity to transform the ways in which we manage our health,” said John E. Kelly III, IBM senior vice president, solutions portfolio and research. “We need better ways to tap into and analyze all of this information in real-time to benefit patients and to improve wellness globally. Only IBM has the advanced cognitive capabilities of Watson and can pull together the vast ecosystem of partners, practitioners and researchers needed to drive change, as well as to provide the open, secure and scalable platform needed to make it all possible.”

REAL-TIME DATA

IBM is collaborating with Apple, Johnson & Johnson and Medtronic to create new health-based offerings that leverage information collected from personal health, medical and fitness devices. The results will be better insights, real-time feedback and recommendations to improve everything from personal health and wellness to acute and chronic care. These relationships are non-exclusive, and IBM anticipates many more companies to leverage the Watson Health Cloud platform. IBM and Apple will expand its partnership with IBM Watson Health Cloud to provide a secure cloud platform and analytics for Apple’s HealthKit and ResearchKit. This will support health data entered by customers in iOS apps and also arm medical researchers with a secure, open data storage solution with access to IBM’s most sophisticated data analytics capabilities Johnson & Johnson will collaborate with IBM to create intelligent coaching systems centered on preoperative and

postoperative patient care, including joint replacement and spinal surgery. Solutions will be mobile-based, accessing the Watson Health Cloud and leveraging IBM Watson’s cognitive capabilities. Johnson & Johnson will also look to launch new health apps targeting chronic conditions, which currently cost consumers as much as 80 percent of the $7 trillion global healthcare spend. Medtronic will leverage the Watson Health Cloud insights platform to collaborate with IBM around delivery of new highly-personalized care management solutions for people with diabetes. The solutions will receive and analyze patient information and data from various Medtronic devices including insulin pumps and continuous glucose monitors, and use this information to provide dynamic, personalized diabetes management strategies to patients and their providers.

50 million unique patients, 360 hospitals, and more than 317,000 providers. Market intelligence firm IDC just named Explorys global leader in Healthcare Clinical and Financial Analysis. Phytel develops and sells cloud-based services that help healthcare providers and care teams work together to ensure care is effective and coordinated in order to meet new healthcare quality requirements and reimbursement models. It was just named the leader in the population health management category by the 2014 Best in KLAS Awards: Software & Services. The acquisitions bolster IBM’s efforts to apply advanced analytics and cognitive computing to help primary care providers, large hospital systems and physician networks improve healthcare quality and effect healthier patient outcomes. Terms were not disclosed for either deal.

ACQUISITIONS

Building on strengths in cognitive computing, analytics, security and cloud, the new Watson Health unit aims to dramatically improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud platform allows this information to be anonymized, shared and combined with a dynamic and constantly-growing aggregated view of clinical, research and social health data. IBM and its vast ecosystem of clients, partners and medical researchers can surface new connections between these diverse and previously siloed healthcare data sets, and spur the creation

To complement its existing capabilities, IBM has reached agreement to acquire Cleveland-based Explorys and Dallasbased Phytel, two healthcare technology companies that are widely recognized for their leadership in applying Big Data and analytics to help improve the quality of health for individuals and large population groups. A spin-off from the Cleveland Clinic in 2009, Explorys’ secure cloud-computing platform is used by 26 major integrated healthcare systems to identify patterns in diseases, treatments and outcomes. It integrates more than 315 billion clinical, financial and operational data elements, spanning

WATSON

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THEPRACTICE of a new generation of data-driven applications and solutions designed to advance health and wellness. Individual patients and larger health populations alike will benefit as providers share and apply those insights in real-time to drive better, faster and less expensive treatments. The medical community is one of the earliest adopters of Watson cognitive computing technology, where IBM has collaborated with leading hospitals and research institutes including Memorial Sloan Kettering Cancer Center, University of Texas MD Anderson Cancer Center, the Cleveland Clinic, the Mayo Clinic and the New York Genome Center to advance Watson’s healthcare capabilities and to help transform how medicine is taught, researched and practiced. Innovative partners including Welltok, Modernizing Medicine, Pathway Genomics and GenieMD are already using Watson’s cognitive computing capabilities, giving rise to a whole new breed of health apps that are redefining how individuals and organizations think about personal health management. Cognitive computing systems learn and interact naturally with people to extend what either humans or machine could do on their own. They help human experts make better decisions by penetrating the complexity of Big Data. “Watson Health builds on years of collaborative relationships with leaders across the healthcare ecosystem,” said Michael Rhodin, senior vice president, IBM Watson. “The groundbreaking applications of Watson’s cognitive computing capabilities by medical clients and partners clearly demonstrated the potential to fundamentally change the quality, efficiency and effectiveness of healthcare delivery worldwide. We’re excited to broaden access to world-class technology and to work with our partners to transform health and wellness for millions of people.” IBM will open a headquarters location for the new unit in the Boston area and expand its Watson presence in New York City. It will dedicate at least 2,000 consultants, medical practitioners, clinicians, developers and researchers to design, develop and accelerate the adoption of Watson Health capabilities. The new unit will include IBM’s existing Smarter Care and Social Programs practice, which was created three years ago following the acquisition of Curam Software, a leading provider of health and social program management solutions. IBM has received more than 1,300 patents in healthcare, life sciences and medical devices. Its invention of the excimer laser used for LASIK surgery was awarded the National Medal of Technology in 2011, and Blue Gene, the first supercomputer to successfully model protein-folding, received the award in 2009. VT N

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TAKE THE LEAD.

Internet Marketing Strategies for Success HIPPA COMPLIANT WEBSITES By Gregg Nell Medical professionals in the vein industry put quality patient care at the forefront of their practices – and rightly so. As a patient, you expect a safe environment, professionalism and Gregg Nell a good relationship with your doctor. Most patients have also come to expect that same level of service from their doctor’s website. However, in the busy world of healthcare, website functionality, design, maintenance, hosting, etc. often gets put on the backburner for the more urgent aspects of running the practice. But as the saying goes, <ital.>what you don’t know can hurt you,<endital> and letting your online presence fall by the wayside can be detrimental to your business. For example, what if you weren’t familiar with the concept of a HIPPA compliant website? Or weren’t sure if you needed one? Or didn’t know that you could face security breaches, lawsuits and financial devastation if you didn’t comply? In short, a HIPPA compliant website abides by the HIPPA security standards. The Health Insurance Portability and Accountability Act was introduced in 1996. Thirteen years later an unrelated act was signed that incentivized the use of electronic records. In order for HIPAA to keep up with the changing times, the HIPPA omnibus rule was released in 2013. In other words, HIPPA is more focused on electronic protected health information (ePHI) than ever before. As a medical provider, it’s important to understand the basics and know your options in the ever-evolving landscape of online healthcare. Here’s a breakdown of what it means to have a HIPPA-compliant website and who this standard applies to.

HOW DO I KNOW IF I NEED A HIPPA COMPLIANT WEBSITE?

Today’s health and wellness industry is a modern one. Patients expect 24-hour access

be encrypted. So even if e-mail is secure leaving your system, if it’s opened via an insecure account, you’ve got a possible HIPPA breach. Many healthcare providers will play it safe and not put HIPPA-sensitive information in e-mail form, rather, the e-mail will contain a notification prompting the recipient to access an online portal.

GETTING STARTED

to electronic health information, both public and private. Most of the amenities that come along with this luxury – registering new patients, scheduling appointments, remote medicine, electronic prescriptions, etc. – require a HIPPA complaint website. Do any of those apply to you? The HIPAA omnibus rule expanded on this to include your relationships with covered entities. So even if your website doesn’t justify HIPPA compliance, if you have contracts with healthcare providers that DO require HIPPPA compliance, then you’re directly liable. Your website must follow suit. If your website is primarily used to provide information about your practice, chances are you don’t need to be HIPPA compliant. For example, asking a user to fill out a simple form about preferred appointment times (name, email address, preferred time) does not itself require a website to be HIPPA-compliant because no medical information is being transferred. However, requiring that patient to list symptoms they’d like to discuss during their appointment, does.

WHAT MAKES A WEBSITE HIPPA COMPLIANT?

The HIPPA law is unusual in that it consists of both recommendations and requirements, all of which focus on e-PHI security. A website development team with HIPPA knowledge will be able to speak to which are mandatory and which are optional. There are six overarching categories.

INFORMATION BACKUP: Even if your system crashes, you must have the means of backing up and retrieving e-PHI. This is standard on most websites anyway, but not all. PERMANENT DISPOSAL: Some website providers will keep data forever, but a true HIPPA compliant website will have the ability to delete e-PHI indefinitely when it’s no longer needed. INTEGRITY: Simply put, this means HIPPA protected information must not be altered or tampered with. DATA ENCRYPTION: e-PHI must be encrypted when it’s stored and transported (for example, sending an RX from your website to the pharmacy). This is often a web development add-on that standard sites don’t have. SECURE AUTHORIZATION: e-PHI should only be accessible by authorized personal. In its simplest form, “secure authorization” is like logging into your email account. HIPPA requires websites to take that one step further with unique, audited access controls. HOSTING: A true HIPPA compliant website must be hosted on a HIPPA-compliant server. This could be in-house or on a server of a company you have a HIPAA Business Associate Agreement with.

WHAT ABOUT E-MAIL?

Although your e-mail provider may not be directly related to your website, HIPPA compliance still applies. This means any e-mail you send or receive that contains e-PHI must

First things first – get informed. Understand the basics of electronic HIPPA compliance and determine where your own website falls. Does it need some minor tweaks or a complete overhaul? Even if your website is up to par, what about your e-mail policy? Then, call in the professionals. Working with a website development team that knows the rules, regulations, and ins-and-outs of HIPPA-compliant technology will ensure that you’re getting a quality, safe, secure product. And be picky. Some web development agencies offer these services but don’t pay attention to detail or follow through on the nuances. For example, a company working on a HIPPA-compliant website should have a “safe room” that allows developers to work in a secure environment should they need to deal with HIPPA-sensitive information (like testing the backend of a patient portal). All developers should also complete a HIPPA certification class. As a medical professional, patient care is your first priority. With the ever evolving world of electronic health and wellness, ensuring that their personal information is safe has become part of that care. Having a HIPPA compliant website also protects your practice from potential legal and financial devastation. Talk with your web development team about how you can improve your website’s safety and your own sense of security. VT N Gregg Nell is the director of Digital Marketing Strategies at Vein Specialists of America. He can be reached at (312) 550-9349 or Gregg.Nell@ veinbusiness.com.

JUNE/JULY 2015 < VEIN THERAPY NEWS

THEPRACTICE What is ICD-10? StreamlineMD has a readiness plan The International Statistical Classification of Diseases and Related Health Problems — 10th revision is used to report signs, symptoms, abnormal findings, complaints, social circumstances and external causes of injury or diseases, as classified by the World Health Organization. PRC Medical/StreamlineMD has an ICD-10 readiness plan for clients, because time is running out — again. The Oct. 1 deadline for switching to ICD-10 is, at this time, a reality. On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. No. 113-93) was enacted, which states that the Secretary may not adopt ICD-10 prior to Oct. 1, 2015. Accordingly, the U.S. Department of Health and Human Services expects to release an interim final rule in the near future that will include a new compliance date that would require the use of ICD-10 beginning Oct. 1. The rule will also require HIPAA-covered entities to continue to use ICD-9-CM through Sept. 30, 2015. There are some significant differences between the ICD-9 and ICD-10 Code Sets. ICD-9 code is 3-5 characters in length, while ICD-10 is 3-7 characters long. There are about 13,000 codes in ICD-9, but about 68,000 in ICD-10. In ICD-9, there is limited space for adding any new codes, but ICD-10 is flexible for adding new codes. In ICD-9, the first digit may be alpha (E or V) or numeric; digits 2-5 are numeric, but in ICD-10, Digit 1 is alpha; digits 2 and 3 are numeric; digits 4-7 are alpha or numeric. ICD-9 lacks detail, while ICD-10 is very specific; and ICD-9 lacks laterality (that is codes identifying right or. left), and ICD-10 has laterality. The PRC Medical/StreamlineMD ICD-10 Readiness Plan consists of the following elements: • Coder Training: StreamlineMD certified coders completed ICD-10 training and are prepared to assist you by request. • Client Awareness Assistance: StreamlineMD began publishing newsletter articles beginning in October 2013 to educate its clients on what ICD10 means as it relates to coding and documentation. In the preparation of the Oct. 1, 2015, ICD-10 extended deadline, the company will publish additional newsletters in mid 2015. Medical practices should also take steps on their own to increase awareness.

VSA gets your vein practice seen online!

Web Design & Development | Search Engine Optimization Paid Search Campaigns | Social Media Campaigns Contact us to learn more about our digital marketing solutions! Gregg Nell Director of Digital Marketing gregg.nell@veinbusiness.com gregg.nell@veinbusiness.com Tel (312) 550-9349

Vein Specialists of America, Ltd. 900 Oakmont Lane, Suite 100 Westmont, IL 60559 www.veinbusiness.com www.VeinBusiness.com

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continued on page 30

VEIN THERAPY NEWS < JUNE/JULY 2015

THEPRACTICE

Relationship Marketing Strategy Errors By David P. Schmiege

I have started to notice more and more marketing firms offering the concept of direct to referral physician marketing progra ms across the country. I am pleased to see this as David Schmiege it confirms my belief dating back to 1985 that direct marketing was the best return on investment for most medical specialty practices. However, I am dismayed by the approach of many of these firms. A physician liaison, or physician relations manager, is a professional salesperson dedicated to representing your medical practice in an effort to establish and strengthen the relationship between existing/potential referring physicians and your medical practice. By maintaining an open line of communication with referring physicians and performing diligent community outreach, physician liaisons maintain and grow the patient referral base for those they represent. An effective physician relations program can have a powerful effect on the growth of your vein practice by increasing patient referrals and subsequent consultations/ procedures. There are, however, several common errors in approach and understanding that can slow your success and even derail it altogether. Some of these mistakes come from inexperience — for example, doctors, nurses and office managers not being exposed to a sales-driven business culture. Other industries outside of healthcare have long viewed the sales or business development function as a vital component of their business models, and yet medical practices are not uniformly on-board. Past marketing campaign failures, insufficient relationship marketing program knowledge, out-of-date marketing concepts and/or inaccurate beliefs about business development can take your relationship marketing program in the wrong direction. However, the good news is that there is tremendous potential for growth in those medical practices that obtain competency in professional business development. For that reason, you might want to consider how your

practice is performing compared to critical strategy errors described below that can derail your success. This article will share with you my thoughts and experiences gained from thirty years invested as a physician practice management and marketing advisor. 1. Physicians often have difficulty when hiring a physician liaison to establish and expand relationships with existing and potential referring practices. Some marketing organizations suggest that you promote/ recruit an RN for this position. Based on my experience, this strategy rarely works. It’s apples and oranges, a square peg in a round hole. RNs are not trained in professional sales and their listening skills are different, based upon their clinical training. RNs are trained to tell you what they know, based upon their clinical training – A physician liaison (i.e., experienced pharma rep) is trained to ask questions and listen to the needs of the referring physician. Referring physicians don’t want to be told, they want to be heard and then reassured that patients that they refer to your practice will receive adequate care that reflects positively on the referring physician. 2. Training, education and experience are important qualifications for this position. Pharmaceutical companies and medical device manufacturers spend between $7,500 and $10,000 annually, <ital.>per sales rep,<ENDITAL> in sales training expenses in order to train their reps to ask the right questions that meet the needs of their clients in a professional manner. Nothing can replace experience … and yet medical practices try to short-change this continually. 3. Experience teaches your physician liaison to develop a marketing strategy, manage their time, prioritize their referring physician target list, identify hidden decision makers, respond in a timely manner, develop sales tools that referring physicians value which get their foot in the door, build honest relationships that result in trust, etc. on and on and on. 4. Using a service area call schedule that has your physician liaison operating according to a “newspaper route” or “crisis” style. This means that you set up either a standard cycle of “deliveries” without regard to your referring physician’s needs or by “crisis” — the problems / issues the physician’s office has with your vein practice.

I recommend a more strategic approach where a physician liaison develops a call schedule that targets specific referral physicians who meet a predetermined “best-fit” criteria for referring to your vein practice. 5. Considering relationship marketing as part of your advertising campaign. Relationship marketing adds enormous value to your vein practice. However, considering relationship marketing as part of your advertising campaign can create a misunderstanding around purpose and expectations, interfere with relationship marketing’s mission and inevitably dilute the impact that both disciplines can have in growing your practice. View your physician liaison program as a separate entity, one that relates to marketing but has its own strategic goals, implementation plan, budget and ROI measurements of success. 6. Depending on referral physician site visits that emphasize “information download.” Using a steady stream of clinical information does not allow the physician liaison to fulfill the important task of uncovering, considering and addressing the referral physician’s needs. If a physician liaison really wants to build relationships with referring physicians, they need to work toward having their vein practice viewed as a trusted clinical advisor and not a pusher of treatment options. Hand delivering consultation reports, post-procedure treatment reports, clinical case studies, etc., develops a mutually beneficial referral relationship. 7. Unrealistic expectations of how much of a workload the physician liaison can handle and still be effective. Some practices see the role of their physician liaison as responsible for calling on a large number of existing and potential referring practices, as well as community education outreach activities, all within a 15 or 20 mile radius of their practice. In many instances, I have seen physician liaisons with the added responsibility of developing, implementing and monitoring all print and media campaigns for the practice, as well as producing marketing materials … all activities which take your physician liaison away from relationship marketing. Relationship marketing initiatives and advertising campaigns can have a direct and enormously positive impact on your practice. To have the fullest impact, you need a balanced plan that is targeted, that sets goals and strategies for both retention and new patient acquisition, and that determines the

differing tactics required for each of these two segments. 8. Sending a physician liaison into the field with insufficient information and training. When a physician liaison goes into the field with little or no information about your practice, vein disease, available treatment options, as well as current referral patterns of the targeted practices, they are not prepared to have a “consultative conversation.” Not only does this lack of preparation make it unlikely that the liaison will engage the targeted referral physician, it further alienates the referring physician and makes it more difficult for the liaison to get back in the door for a subsequent meeting. So, it is crucial that your liaison is trained to know how to qualify a referring physician, the type of information that will lead to an engaging conversation with a referring physician and/ or their staff, and the questions to ask to uncover the referring physician’s specific challenges and needs. All of this is necessary to begin building a solid, long-term relationship with a referral source. 9. Assigning a physician liaison the responsibility to develop and manage the relationship marketing program. A common situation I have encountered in struggling programs is a physician’s expectation that the individual hired to be the physician liaison is also qualified to take responsibility for developing the program, determining marketing strategy, and monitoring its activity and results.

WHERE TO FROM HERE?

You may have seen that one or two or even several of these issues are preventing your relationship marketing efforts from reaching full potential. Hopefully by bringing these issues to light, changes can be made in your practice. Possibly you see where mistakes may be taking place, but you’re not sure of what your next step should be? Call me or send me an email with your questions and I will respond accordingly. Have an idea for a future article? As a regular contributor to VTN, I am always looking for topics to discuss in future articles. VT N David Schmiege is the president and CEO of Vein Specialists of America Ltd. He can be reached at 630-638-0060 or at David.Schmiege@VeinBusiness.com.

JUNE/JULY 2015 < VEIN THERAPY NEWS

THEPRACTICE PHYSICIAN TIERING: What’s your tier? By Sean M. Mullen One of my customers recently forwarded me an article he had found in the American College of Surgeons May Bulletin. It was a statement issued by the College’s Health Policy and Advocacy Group concerning the new narrow networks and physician tiering being implemented by payers across the nation. The article was interesting to me in that it illuminated the extent to which tiering is taking place at payers. This revelation led me to dig deeper by going to various blogs and payer websites. What I discovered is alarming. Whether or not you are aware of it, you are likely being tiered by some if not many of your payers. You are also likely not included in one or more narrow network. Patients’ out of pocket costs can be significantly higher (2 or 3 times higher in some cases) depending on your tier. The criteria for tiering are cost and quality (i.e. value). The payers are unlikely to reach out to you; rather, they will make their own determination behind the scenes with whatever data (accurate or otherwise) they have. The specific metrics being used are not always disclosed, and different payers may tier you differently making the process seem arbitrary. It stands to reason that providers who reach out to payers proactively, negotiate price and provide outcomes (quality) data are at a decided advantage. This only reinforces the point I made in my article in the last Vein Therapy News issue – if you are not being proactive with your payers and you are not able to demonstrate quality outcomes, don’t be surprised if you see a slow but steady decline in patient volume over the coming years. Now is the time to take action. VT N President Sean M. Mullen founded StreamlineMD in 2004. He holds an AB from Columbia College and an MBA from Columbia Business School. StreamlineMD, a subsidiary of PRC Medical, has a large installed base of vein clinics and has the only EMR that is certified to upload clinical data to the ACP Pro Venous Registry. StreamlineMD has physician practice customers in 39 states. Mullen can be contacted by e-mail at smullen@streamlinemd.com or by phone at 330-564-2664.

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SECONDLOOK

Dr. Charles B. Ross: “Why I use UA-CDT as the predominant intervention for submassive PE”

By Larry Storer Charles B. Ross, MD, FACS, chief of vascular and endovascular services at Piedmont Heart Institute in Atlanta, sat down with Vein Therapy News to discuss current practice, challenges and opportunities in the management of pulmonary embolism , including his experience with ultrasound-accelerated, catheterdirected technology (UA-CDT). Dr. Ross earned his medical degree from the University of Kentucky College of Medicine in 1984. He served his residency in general surgery at Vanderbilt University and his vascular surgical fellowship at the Louisiana State University Health Sciences Center in New Orleans. Dr. Ross is board certified in Vascular Surgery. He is a Fellow of the American College of Surgeons, and he is a member of the Southern Association for Vascular Surgery, American Venous Forum, and Society for Vascular Surgery. Immediately before joining Piedmont Heart Institute in 2012, Dr. Ross served as associate professor of Surgery and chief of the Division of Vascular Surgery and Endovascular Therapeutics at the University of Louisville School of Medicine. His practice in Louisville included venous interventional services for both Norton Hospital and Kosair Children’s Hospital. Since his arrival at Piedmont Heart institute, Dr. Ross has led the development of a robust major venous interventions service, including care for patients with pulmonary embolism. Dr. Ross has no financial disclosures to report with regard to EKOS Corp., the primary manufacturer of EkoSonic System that delivers Acoustic Pulse Thrombolysis Treatment (ultrasound accelerated lysis). Dr. Ross is the site Principal Investigator for the ACCESS PTS and OPTALYSE PE Trial, both trials sponsored by EKOS Corp., to begin enrollment at Piedmont Atlanta Hospital in 2015. VTN: Please discuss the usual standard of care of treating patients with pulmonary embolism (PE) and the challenges, risks and effectiveness of that treatment. DR. ROSS: Pulmonary embolism is the third leading cause of cardiovascular mortality. The primary goals of treatment are to reduce mortality and the incidence of cardiopulmonary disability from the PE. Relative to advances made in the management of disease processes, such as coronary artery disease and diseases of the aorta, progress in the management of acute PE has lagged. The usual standard of care for all patients with PE has been systemic anticoagulation combined with critical care measures supporting oxygenation, ventilation and blood pressure. Building upon this foundation, in the case of hemodynamically unstable patients, the standard traditional algorithm escalates to systemic thrombolysis or surgical pulmonary embolectomy, when systemic thrombolysis is contraindicated or patients fail to respond. Both systemic thrombolysis and surgical pulmonary embolectomy are effective therapies. However, systemic thrombolysis carries a significant risk of major bleeding complications including intracranial hemorrhage, a risk so concerning to clinicians that most patients who clearly need systemic thrombolysis may not be getting it. And, surgical embolectomy often is not readily available or is not even considered until it is too late to be effective. So, the arrival of less-invasive and more readily accessible treatment options for PE, as well as clinical trials documenting their efficacy and safety, has been greeted with great interest by those of us who are consulted to manage PE. Depending upon the acuity of a patient’s presentation, these options range from

Charles B. Ross, MD, FACS low-dose systemic thrombolysis all the way to stabilization with extracorporeal life support, followed by catheter-based therapies or surgical pulmonary embolectomy. Options are highly dependent upon institutional resources and teams. At Piedmont Atlanta Hospital, management of PE is part of our Level I Vascular Emergency Service, follows a well-defined care plan, and is conducted by a multidisciplinary team led by critical care pulmonologists, along with endovascular surgeons, the interventional cardiology shock team, and cardiothoracic surgery. Central to the implementation of new treatment protocols and devices has been the development of an understanding of the natural history of PE and stratification of risk. Most PEs are minor and carry a low risk of early mortality. In contrast, 3 percent to 5 percent of PEs are massive, defined by hypotension with a systolic blood pressure less than 90mmHg, and carry a risk of death at 90 days as high as 30 to 50 percent. Sub-massive PEs are large, central PEs in hemodynamically stable patients who have associated right ventricular dysfunction manifested by elevated biomarkers such as BNP and troponin and evidence for right ventricular dilatation by CTA or Echo. These patients are at risk for hemodynamic collapse acutely, and over the course of 90 days, intermediate risk for fatal events. Newer therapies such as Ekosonic ultrasound-assisted, catheterdirected low dose thrombolysis, cleared by the FDA for the treatment of pulmonary embolism in May 2014, have demonstrated efficacy in reducing right ventricular dysfunction in cases of submassive PE and have thus begun to revolutionize treatment of this disease process. As far as current challenges are concerned, our first challenge is to better educate frontline colleagues to rapidly recognize patients with submassive and massive PE, and we must demonstrate to them the safety and efficacy of today’s advanced, lessinvasive options. The simple act of stratification may facilitate early intra-institutional consultation or transfer to centers with greater resources where a life may be saved.

Beyond educating front line physicians to recognize those patients with PE who can benefit from advanced therapy, those of us who are part of multidisciplinary teams offering advanced life support and interventional therapies face many exciting but hard challenges. PE patients are not homogeneous. First, they bring with them their pre-existing comorbidities established before the PE. So, a large thrombus burden, central PE which barely produces dyspnea in one patient may produce hemodynamic instability in another. Secondly, even within the cohorts of massive and submassive PEs, the spectrum of cardiovascular and respiratory dysfunction may be quite variable. Hence, in the case of massive PE, for example, decisions regarding when to change from inotropic pressor support to ECLS for life support, while in the process of moving towards intervention, can be challenging. As far as submassive PE is concerned, the projected benefit of treatment as compared to risk is not always clear. The decision to aggressively intervene in a healthy 45-year-old corporate executive who becomes dyspneic with PE while deplaning at the airport is far easier than making the same decision in patients advancing into their seventh or eighth decade of life. Our capability to successfully intervene with various therapies presently exceeds the data we have to guide therapy, and clinical judgment is used in many cases to match patients and therapeutic modalities. In these situations, patient safety is paramount, and the safety profile of the EKOS system for treatment of PE with low-dose thrombolysis makes it uniquely attractive. VTN: How does ultrasound-assisted catheter-directed lowdose thrombolysis mitigate the risks or limitations of usual care and improve outcomes? DR. ROSS: I have been using the UA-CDT Ekosonic system to treat PE since 2010. Initially, I used it to treat patients with massive PE who had been stabilized with ionotropic support. Over the past four years, with publications of the results of individual series as well as Ultima and Seattle-II, and with the development of our multidisciplinary approach to PE at Piedmont Atlanta Hospital, UA-CDT has been the predominant intervention I have used for PE. In our experience, the risk of major bleeding complications has been minimized. The treatment has been well-tolerated. We have had patients who presented with very impressive PEs return to work within two weeks. Although we have not studied our patients with six-minute walk tests nor quality of life instruments, it has been our team’s observation that these patients return to full activity much sooner than historical experience with anticoagulation alone. VTN: Which patients with PE are appropriate for this procedure? DR. ROSS: The most appropriate patients are those who present with sub-massive PEs, are healthy, less than 70 years of age, and have no contraindications to thrombolysis. As an individual’s risk for complications increases due to associated comorbidity or age, such patients are considered for treatment on a case by case basis thru risk:benefit analysis. Massive PEs who have been stabilized on minimal support have also done well in my experience. Hemodynamically unstable patients with large burden, central PE including thrombus in-transit are not appropriate for UA-CDT. These patients are best managed in the operating

JUNE/JULY 2015 < VEIN THERAPY NEWS

SECONDLOOK the approach with a 0.035 guidewire to traverse the tricuspid and pulmonic valves and to select the pulmonary artery, and then, I telescope the sheath over the catheter and wire into the pulmonary trunk. Baseline PA pressure is measured, and a pulmonary arteriogram is obtained. The first EKOS catheter (usually a 106x12) is placed. Working through the second access site, the second EKOS catheter is placed in the opposite pulmonary artery. The TPA infusion is initiated in the lab. The catheter systems are secured to the thigh with an IOBAN occlusive drape. In morbidly obese patients or in those who are unable to lie relatively flat for the infusion period, we use dual access in the right internal jugular vein. Cath lab times relate to the entire procedure prepping the patients, mixing the drips and starting them, etc. Average actual procedure times are less than an hour.

Dr. Charles B. Ross, with Dr. Robert Powers observing, is performing a pulmonary embolism intervention recently in lab 6 at the Piedmont Heart Institute. room with prompt surgical embolectomy or perhaps AngioVac thrombectomy, with immediate back-up availability for conversion to VA ECMO. We have successfully used UA-CDT to treat one patient stabilized on ECLS while concomitantly on circuit. And, this has been reported by others as well. Severe shock demands life support, and UA-CDT is just not appropriate as a stand-alone intervention in such circumstances. VTN: How many patients have you treated with this approach? DR. ROSS: We have treated approximately 48 patients since late 2012, with volume seeming to increase monthly. VTN: What has been your clinical experience with the technology’s therapeutic effects? DR. ROSS: The most important aspect of judging the effect of UA-CDT is the clinical response of the patient. Most patients report feeling better within within just a few hours of initiation of therapy, and in my experience, the more severe the PE, the more dramatic has been their clinical response. We use pulmonary artery pressure as our usual endpoint, aiming for at least a 20 percent decline before cessation of therapy. We try to limit cost of therapy, as well as unnecessary radiation and contrast exposure, and so, we do not routinely repeat CTAs or return to the lab for repeat pulmonary angiograms. We tightly control concurrent anticoagulation with heparin with PTTs targeted towards 50 to 60 seconds, but certainly no higher than 70 secs. Our usual rate of TPA infusion has been between 0.5 and 1.0 mg/lung/hour – depending upon thrombus burden and perceived bleeding risk in each patient. We monitor fibrinogen levels at treatment onset and every 6 to 8 hours. With this practice, we have experienced no alarming swings in fibrinogen levels, no intracranial hemorrhage or other neurological events and no major bleeding complications in our submassive group.. Patients have rarely required transfusion sup-

VEIN THERAPY NEWS < JUNE/JULY 2015

port, and when transfusions have been given, it has related more to the patient’s underlying comorbidity and anemia. VTN: How strong do you think the data are from the ULTIMA and SEATTLE II trials for supporting the use of this technology in treating PE? DR. ROSS: Both ULTIMA and SEATTLE II showed significant early improvement in right ventricular function with UA-CDT as opposed to anticoagulation. And, no patients in the UA-CDT groups experienced hemodynamic collapse once therapy had been initiated. So, the real questions are whether early improvement in right ventricular function can be used as a surrogate for long-term benefit in terms of mortality, and whether early thrombus reduction relates to decreased chances of late chronic thromboembolic pulmonary hypertension. Most important to me, ULTIMA and SEATTLE II confirmed that this therapy is safe. The clinical response and hospital course, as well as early improvement of UA-CDT treated patients after discharge relative to historical experience, has been enough to convince me that the therapy is beneficial. VTN: Describe step by step how you do the procedure using UA-CDT. How long is the average procedure? DR. ROSS: We position the patient supine on the cath lab table. Supplemental oxygen is continued, vital signs monitored and oxygen saturation is monitored. We review the clinical situation as part of our procedural time out. I either know the result of lower extremity venous scan or I do a quick ultrasound myself to plan venous access to avoid thrombus. Both groins are prepped or the right neck is prepped. Dual access is obtained with ultrasound-guidance and micropuncture needles – access sites about 1cm apart. Sheaths are placed, and an inferior vena cavagram is done. I often place a retrievable filter at this time when residual thrombus burden is either high or unknown. I use various 5F diagnostic catheters depending on

VTN: How difficult was the technology to master? DR. ROSS: Not difficult. I do not generally try to do presentation quality, higher contrast volume pulmonary arteriograms because I almost always have a pre-procedure CTA. Hence, the pulmonary angiogram is more for localization than diagnosis. In some patients having unusually large right ventricles that are severely dysfunctional, selecting the pulmonary artery can take a bit more time. But, we have had no cases in which we could not instrument both pulmonary arteries. Additionally, our cath lab team at Piedmont Heart Institute picked up the procedure handily. Basically, their familiarity with right heart catheterization combined with their familiarity with EKOS as used in our center’s major venous interventions program made PE management easy for them to master. Catheter and sheath management have been supported through outstanding participation and leadership on the part of our critical care pulmonologists and their mid-level team. All in all, the technology has been introduced smoothly. VTN: Are there any limitations of the technology? DR. ROSS: Given the resources we have at Piedmont Atlanta Hospital, I would not use EKOS in the case of a patient experiencing active hemodynamic deterioration without the support of the interventional cardiology shock team. As mentioned above, thrombus in transit and massive, central PE with hemodynamic collapse should be managed by other techniques. Additionally, situations in which patients have been symptomatic for more than two weeks may require longer treatment, more thrombolytic agent, and may still not receive the same benefit as those who reach us with more acute symptomatology. This scenario requires further study. VTN: What research is still needed to establish the therapeutic effectiveness? DR. ROSS: Long-term outcome studies, optimal dosage and optimal rates of administration of thrombolytic agents, better definition of clinical endpoints to guide cessation of therapy, stratification of subgroups of patients with submassive PE who benefit most from treatment, quality of life measures, and functional testing such as six-minute walks, etc. to develop knowledge of rate of recovery to premorbid baseline, and health economics analysis – just to name a few. VTN: Any other comments about your use of UA-CDT in treating PE? DR. ROSS: The introduction of UA-CDT for PE really stimulated a renaissance of multidisciplinary collaboration at Piedmont Atlanta Hospital. The work has been incredibly rewarding. VT N

SECONDLOOK

New legislation calls for testing ICD-10 code set for 18 months A new bill introduced in the House May 12 would require end-to-end testing of the transition from ICD-9 to ICD-10 by the Health and Human Services Department, and would provide an 18-month transition period to the new code set. The Increasing Clarity for Doctors by Transitioning Effectively Now Act (ICDTEN Act), proposed by U.S. Rep. Diane Black (R-Tenn.), would not stop or delay implementation of the coding system, according to an article in the Journal of the American Health Information Management Association (AHIMA). However, Black’s bill would require HHS to offer the testing to all providers participating in the Medicare fee-for-service program. In addition, the agency would have to submit to Congress certification on whether the system is working, according to AHIMA. If HHS finds that the full transition is not occurring, it would need to take additional steps to ensure completion. During the transition period, reimbursement claims submitted to Medicare could not be denied due to “use of an unspecified or inaccurate subcode.” The deadline for ICD-10 implementation has been delayed several times. Many providers, especially small practice physicians, still have concerns about the transition, with a recent survey finding only 11 percent of respondents “highly confident” their staff will be sufficiently trained by the Oct. 1 deadline to transition to the new code set; 35 percent said they were “not at all confident” their staff will be ready. “Neither Congress nor the provider community support kicking the can down the road and supporting another delay, but we must ensure the transition does not unfairly cause burdens and risks to our providers, especially those serving Medicare patients,” Black wrote in a letter urging fellow legislators to co-sponsor the bill, according to the article. AHIMA officials do not support the proposed legislation, noting in the article that the Centers for Medicare & Medicaid Servicessupported contingency plans already are in place. Margarita Valdez, senior director of congressional relations at AHIMA, said according to the article that the transition period would “create an environment that’s ripe for fraud and abuse.” Meanwhile, AHIMA CEO Lynne Thomas Gordon said she fears that providers would use the extra 18 months to “delay properly learning how to use the new code set.” There are some who would still like to see ICD-10 delayed yet again, or even thrown

out. U.S. Rep. Ted Poe (R-Texas) recently introduced a bill to Congress that would ban ICD-10 outright. The American Medical Association has come out in support of Rep. Poe’s legislation. In a letter to Poe dated May 14, AMA Executive Vice President and CEO James Madara calls the differences between the current ICD-9 code set and the forthcoming ICD-10 code set “substantial,” pointing out that physicians will be burdened financially and administratively by the transition, set to take place Oct. 1. “Implementation will not only affect physician claims submission; it will impact most business process within a physician’s practice, including verifying patient eligibility, obtaining pre-authorization for services, documentation of the patient’s visit, research activities, public health reporting and quality reporting,” Madara says. “Furthermore, not only will physicians face the prospect of significant disruption in claims processing and payment during the transition to ICD-10, any physicians who are unable to transition to ICD-10 by the implementation date simply will not get paid.” In a recent interview with Healthcare Finance, incoming AMA President Steven Stack reiterates the AMA’s position, adding that a better course of action would be to skip ICD-10 altogether. “Let’s just get to ICD-11 and get it done properly,” Stack says. “We believe the problems associated with ICD-10 are so substantial, our policy is we should not move forward with ICD-10.” In a recent post to ICD10monitor.com, Michael Stearns, MD, CEO of Austin, Texasbased Healthcare IT and compliance organization Apollo HIT, predicts that ICD-11 may still be a decade away for use in the U.S. Stearns helped to develop the Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT). Stack says that, should the ICD-10 transition take place, the AMA supports legislation proposed this month by Rep. Black to provide an 18-month grace period to aid providers. “If Health and Human Services moves forward and implements [ICD-10], then we say, there should be a period in which providers should be held harmless,” he told Healthcare Finance. Members of the House Energy and Commerce Committee’s Subcommittee on Health made clear at a February hearing examining ICD-10 implementation that they do not want to see the transition delayed yet again. VT N

ICD-9 stands in the way of children’s quality healthcare By David J. Bailey, MD, MBA If all kids were healthy, we might be able to get by with something called “ICD-9” — an outdated set of medical codes vital to providing care and used internationally since the 1970s to describe diagnoses and procedures. But the truth is that not all kids are healthy and many in our care suffer from rare and chronic diseases. For them and their families, our nation’s repeated delays in adopting an updated code — the International Classification of Diseases-10th Version or ICD-10 — means that physicians and researchers are unable to share valuable data and updated knowledge that could improve their quality of life and, in some cases, mean the difference between a child’s life and death. Let me give you some examples: for starters, ICD-9 codes do not allow physicians to specify whether a condition is in the right or left eye, hand, leg, etc. And, even more importantly, it lumps totally unrelated diseases into common code categories, which has a seriously negative impact on care because the provider cannot make proper diagnosis and tailor treatment. At Nemours, for instance, we treat two rare congenital conditions, one affecting the kidneys and one affecting the brain. But in ICD-9 they are the same code. This means our researchers cannot learn the very latest methods for improving therapies and outcomes from others for two very different diseases. When you care for the sickest of a population, this is a big deal, a really big deal. Healthcare providers and researchers have attempted to work around this enormous roadblock by forming coalitions to study various rare conditions and recode the data so it can be shared broadly on a global scale. But no one group sees enough cases to do effective research, coding systems don’t talk to each other and we can’t share data in a meaningful way until we’re on one common international platform. As a physician and CEO of Nemours Children’s Health System, I hold steadfast to certain crucial principles about our clinical systems: they must promote transparency, usability, data integrity and quality.

The updated version has long been used internationally and would be a vital step forward for patients in improving quality measurement, clinical research and public health surveillance. ICD-10 would also allow U.S. physicians to use their full knowledge of conditions to make the correct diagnosis and describe patients’ progress. A broad-based coalition of nearly 25 hospitals and healthcare organizations are calling on Congress to end a 30-year delay in implementing ICD-10. In 2008, after significant analysis, the Department of Health and Human Services initially planned to adopt the new code by 2011. But implementation has been postponed again and again, now slated for October, 2015. Our patients and families are counting on us. We need ICD-10 to do our jobs more effectively and efficiently, without further delay. Change is always hard, even when we know it will produce better outcomes. I believe that’s why many in healthcare are holding to ICD-9 even though this inertia is in conflict with the scientific principles on which medicine is based. The decades-long delay in implementing ICD-10 has had indisputable consequences for our nation’s children and families struggling with these conditions. Our families deserve to benefit from more timely, specific information that has already been gathered by researchers around the world. At a time when healthcare providers and leaders across the nation are working diligently to increase access and efficiency, improve care quality, and control costs, relying on ICD-9 no longer makes sense. The promise of big data for healthcare in this country is shackled by not having the ability to capture more robust information and provide the best care for children and adults. As health care providers and as a nation, we have an obligation to our patients to insist on no further delays. VT N Dr. Bailey is president and CEO of Nemours Children’s Health System in Jacksonville, Fla. He wrote this article for the Congress Blog in the May 13 issue of The Hill.

JUNE/JULY 2015 < VEIN THERAPY NEWS

SECONDLOOK

Where’s the ROI on EHRs?

Why TVS Procedure Packs?

By Donald Voltz, MD In a recent Health Leaders post, many billions of dollars from private and government funds have been poured into electronic medical records (EHRs) yet the return on this investment has not demonstrated a return. Outside the financial outlay for implementation, training and maintenance of these systems, many other issues are affecting healthcare delivery and safety for patients. An overall lack of user interface design (UI), poor or no interoperability and minimal ability to customize the EHR platforms to more effectively meet the needs of our patients. There is no question that the primary driver of implementing EHRs in medicine is to improve the delivery of care to our patients in a safe and efficient manner. Development of thoughtful user interfaces that address the needs of various healthcare providers can appear to be unnecessary and window dressing to make physicians happier when interacting with computers, but it is a requirement for better data visualization and to prevent missing critical information. In addition, design relates directly to how information is understood and communicated both between healthcare providers, as well as for patients to better understand their disease and the plan of treatment. All of the major EHRs are using standard components to present data. None of them have successfully replicated the viewing of complex, interrelated data such as that displayed on a paper ICU record. With this lack of UI design, providers are forced to search through various areas of the EHR to locate it. In addition, when a specific piece of data cannot be found, one is unsure if the data was collected or was added to some arcane location. Outside of this frustration and possible duplication of work, a lack of UI design allowing for viewing interrelated or interdependent information requires providers to hold the information in their mind until all of the various pieces are collected. The simple act of finding a pre-operative blood glucose value so that it can be documented in my pre-operative evaluation can be a challenge with many of the systems I have

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EHRs

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VEIN THERAPY NEWS < JUNE/JULY 2015

SECONDLOOK

Are you doing data entry more and enjoying it less? Editor’s note: I get to see my nephrologist just twice a year, and the time we spend discussing my strengths and weaknesses is of overriding importance to me. Increasingly over the years, that post-checkup discussion time has gotten shorter and shorter as he has to spend so much time at his computer while and I am sitting there. So, finally I had to whine about this fleeting face time. Turns out, he is as frustrated as I am. The next day, I ran across a post on the same topic by Dr. Linda Girgis MD, FAAFP, a family physician who treats patients in South River, N.J., and who blogs regularly at “Dr. Linda’s Blog (http://drlinda-md.com/).

By Linda Girgis, MD, FAAFP Last week, while walking through the hospital corridors, I overheard two patients conversing. One of them said that doctors only care about their computers and not patients. I held my tongue lest I seem to be eavesdropping. But, nothing could be further than the truth. Most doctors loathe the work they do in their EHRs. Most of us were not given an option in adopting this technology. The HITECH Act signed into law on February 7, 2009 gave birth to the Meaningful Use (MU) Program. While this was initiated as a bonus program for doctors implementing EHRs into their practices, it evolved into a penalizing system for those who do not comply with all its requirements. Doctors who do not participate in the MU program are currently docked in reimbursements from CMS. This penalty will grow over the coming years and become a substantial penalty for many. Having records in digital format that are easily accessible is a fine goal. However, EHRs were not devised to fit in easily into a doctor’s work flow. They disrupt time being spent to discuss the patient. I hear many patients complains that doctors spend too much time looking at their computers. This is not because we enjoy doing this. We need to document encounters in these EHR systems or face financial penalties on work we are doing.

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worked with. Although this is one small issue that many would agree is insignificant, but when small items are missed or multiple items become compounded, patients are placed at risk. Given we are still in the early phases of Healthcare IT and there is an overall lack of standardization for these types of issues, they are impacting how physicians and other providers practice. A somewhat related issues, not on the front end display but lingering in the background is storage of medial data. Database design is not only lacks standardization but also has not been normalized to allow for the easy sharing of information between systems. This results in much duplication of data as well as tests and studies into different medical record systems. Not to mention, interoperability has not yet been solved, creating frustration and concerns on Capital Hill with EHR providers. Work on interoperability is being

Not only is the software time consumptive because of inadequate technology, the MU mandates worsen this. We are required to report a whole series of metrics that prove to the government that we are using our systems in a meaningful way. This is the aspect that consumes the most time. The metrics are onerous and often things that are not necessary for the medical care of our patients. One such example is reporting our patients’ ethnicities. Some of them are of mixed backgrounds and do not fit into any of the categories. Some patients get offended when you

done and the most notable way is through health information exchanges, but the issue is not to duplicate data in a third-party system but to develop a framework where providers can access patient information in a standardized interface, irrespective of the proprietary EHR where it resides. Finally, each of us work within different medical specialties and have varying requirements for medical data. A deluge of information in a tabular format does not promote efficient and safe delivery of information. More proactive design of information display has the potential to affect patient care, improvement physician workflow, and increase patient safety. No matter how minor, it is very difficult to change anything with respect to display and data entry in even the major EHR’s. At its core, we have the tools, frameworks and understanding to deal with great amounts of data, display it in ways to foster understanding and improve communication between providers and patients.

ask what race they consider themselves. For me, race is rarely a consideration except in certain diseases. A 24-year-old college student coming in for a cold should not have to tell us the language he speaks when it is obviously English. Yet, this metric needs to be recorded in his chart for it to count. Patients are growing frustrated by the computers snatching away their face time with their doctors. Many of them lay the blame on the doctors but this does not help the situation. Doctors are equally frustrated from being forced to use technology that does not meld well with our practice of medicine and the metric reporting requirements for MU are onerous. Recently, doctors are voicing their concerns regarding this. However, few improvements have been implemented. EHR companies seek to maximize their bottom line, not doctor’s comfort or efficiency. Similarly, the government seeks access to patient data, as they are getting through the MU reports. Neither of these improve patient outcomes nor satisfaction. These players have become embedded in the very fabric of the healthcare system. MU and forced EHR use is eroding the very sacred doctorpatient relationship. Doctors possess little klout to overcome these mandates. Patients need to take a more active role and understand from where the problem stems. Likewise, their voices should be heard about what this is doing to them. Only when doctors and patients stand side by side to repair this system can any real change ensue. VT N Dr. Linda Girgis MD, FAAFP is a family physician in South River, N.J.. She holds board certification from the American Board of Family Medicine and is affiliated with both St. Peter’s University Hospital and Raritan Bay Hospital. Dr. Girgis also collaborates closely with several universities and medical schools where she teaches medical students and residents. Follow her blog at http://drlinda-md.com/.

Other, data intensive business sectors have developed systems to foster quality care and we will be no different. Companies such as Zoeticx, are working on solutions to these problems, solutions that do not depend on the vendors themselves but allow for customization and interoperability. The most compelling aspect of a middle-ware platform is the ability to engage small development to address niche areas of medicine that are currently not being targeted either because their specific needs fall outside of the standard EHR models or are too small to warrant development resources. Much like medicine itself, EHRs are complex in design and implementation. Although many of the problems discussed in this article are well known and many physicians, administrators and politicians are strongly encouraging vendors to address them, we need to look for other solutions to address not only these current issues but also to be able to respond to unseen needs at the present time.

It is my hope that EHRs are not only able to address the needs of our patients but actually help to empower us to better take care of our patients and enjoy all aspects of medicine, including documentation and access to information in a coordinated and well designed way. VT N Donald M. Voltz, MD, Aultman Hospital, Department of Anesthesiology, Medical Director of the Main Operating Room, Assistant Professor of Anesthesiology, Case Western Reserve University and Northeast Ohio Medical University. Board-certified in anesthesiology and clinical informatics, Dr. Voltz is a researcher, medical educator and entrepreneur. With more than 15 years of experience in healthcare, Dr. Voltz has been involved with many facets of medicine. He has performed basic science and clinical research and has experience in the translation of ideas into viable medical systems and devices. He writes at twitter.com/Donald_M_Voltz.

JUNE/JULY 2015 < VEIN THERAPY NEWS

PRODUCTNEWS Carestream DRX Evolution Plus adds new X-ray features Carestream Health’s newest DRX imaging system — the Carestream DRX-Evolution Plus — adds several major software and hardware enhancements to meet the changing radiology needs and budgets of healthcare providers worldwide. Carestream has steadily expanded the capabilities of the DRX-Evolution platform since it was introduced and the new DRX-Evolution Plus will begin shipping later this year. The system’s modular components, including fully automated systems, have gained wide acceptance among radiology professionals in leading hospitals and clinics. The new DRX-Evolution Plus offers: • A new design with LED lighting for enhanced functionality and aesthetics; • Greater flexibility in high-ceiling rooms via an extended tube column;

• A new high-performance generator designed by Carestream; • An optional table to accommodate patients up to 705 pounds; and • Forward-looking design specifications to embrace future advanced imaging applications from Carestream as they become available. Helen Titus, Carestream’s worldwide marketing director for X-ray Solutions and Ultrasound, said the company has developed more new software features that can boost productivity and enhance the visualization of anatomy, while simultaneously helping to reduce radiation dose. Advanced capabilities of the DRX-Evolution Plus include: • A wall stand Bucky-angulation feature that expedites cross table and other complex X-ray exams; • Tube touch screen that allows a technologist to change techniques and view images from the tube; • Pediatric capabilities including automatic technique and image processing for seven pediatric body size categories; • Bone suppression software for optimized viewing of soft tissue;

• Fast, secure log-in process using RFID badges; • A transbay option that enables fast tube movement across multiple trauma bays, which helps expedite treatment while minimizing movement of critically ill or injured patients; • Automatic acquisition and stitching for long-length and supine imaging exams; and • IHE Dose Reporting to facilitate data sharing with a facility’s dose management system. The DRX-Evolution Plus also offers modular components and configurations and supports a choice of three DRX detectors, including two cesium iodide detectors (35 x 43cm and 25 x 30cm) for high-quality imaging. For maximum productivity, the DRX-Evolution Plus can be configured with a 43 x 43cm fixed detector in the wall stand, and one or two additional wireless detectors that can be used for table Bucky and tabletop exams. VT N READ MORE: carestream.com/news

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VEIN THERAPY NEWS < JUNE/JULY 2015

PRODUCTNEWS

Medtronic's Protégé GPS peripheral stent

Protégé GPS peripheral stent wins FDA OK Medtronic has won expanded approval from the FDA for the Protégé GPS peripheral stent, a product acquired along with Covidien earlier this year for treatment of peripheral artery disease. The Protégé GPS self-expanding stent is already approved for use in the superficial femoral and subclavian arteries. The new approval covers its use in treating stenotic lesions in the common and external iliac arteries, Mark Turco, MD, said. Covidien acquired the Protégé GPS when it paid $2.3 billion for Ev3 in 2010. This year, Medtronic acquired Covidien for $50 billion. The Protégé GPS device is an open-lattice design cut from a nitinol tube that, once deployed, reaches a pre-set diameter to prop open the occluded vessel. “The Protégé GPS self-expanding peripheral stent system is designed to enhance delivery, deployment and visibility during peripheral vascular procedures,” Aortic and Peripheral Vascular Medical Director Dr. Turco said. “This new indication will provide physicians with enhanced device options when treating complex iliac artery disease.” VT N READ MORE: ev3.net/peripheral/intl/se-stents/protg-gps-selfexpanding-peripheral-stent-system. htm

Semler’s PAD test system gets FDA OK Semler Scientific, Inc., an emerging medical risk assessment company that develops, manufactures and markets patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases, has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its next generation peripheral artery disease (PAD) testing system. The next generation system features convenience and ease of use characteristics along with compatibility to electronic medical record systems for easy accessibility of data. The system was designed to fit the needs of Semler’s growing customer base of insurance plans and integrated healthcare delivery networks. The

clearance allows enhanced marketing labeling and messaging to describe the benefits of working with Semler’s disease risk assessment tools. The company expects to launch this next generation system later this year. “It is our intention to make this Semler product the standard of care approach to diagnosing vascular disease,” said Doug MurphyChutorian, MD, chief executive officer of Semler. “We have incorporated product features that we believe broaden the appeal of this Semler system especially to healthcare insurance plans and integrated healthcare delivery systems interested in population health and wellness.” VT N READ MORE: semlerscientific.com

FDA OKs spraydried fibrin to stop bleeding during surgery The U.S. Food and Drug Administration has approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa, manufactured by The Medicines Company’s ProFibrix BV, contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of bloodborne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial. Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge. Karen Midthun, MD, and director of the FDA’s Center for Biologics Evaluation and Research, said this approval provides surgeons an additional option to help control bleeding during surgery when needed. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial Dr. Midthun said. “This eliminates the need to combine the

fibrinogen and thrombin before use and allows the product to be stored at room temperature.” In support of approval, the FDA reviewed data from a clinical study involving 719 participants, over 11 months, undergoing different types of surgical procedures. The study demonstrated Raplixa’s effectiveness by comparing the reduction in the time needed for bleeding to stop when using this fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever and decreased blood pressure. VT N READ MORE: medtronic.com

Medtronic recently launched the In.Pact drug-coated angioplasty balloon for PAD in the United States, becoming the second company to do so following Bard. It went through the more rigorous PMA approval pathway, while Covidien received a 510(k) clearance for the HawkOne in November. Medtronic justified the acquisition of Covidien based on its complementary portfolio of “mid-tech” offerings (as opposed to high tech devices requiring PMA approval) that tended be focused surgical intervention. The HawkOne fits that profile. VT N READ MORE: medtronic.com

GORE EXCLUDER Iliac Branch gets New enhanced HawkOne launched Australian approval in United States for W. L. Gore & Associates’ GORE EXCLUDER Iliac Branch Endoprosthesis, PAD treatment the first complete, fully engineered system The Medtronic HawkOne directional atherectomy system for surgical treatment of peripheral artery disease (PAD) or blocked and calcified arteries in the arms or legs, has been launched in the United States. The device was obtained when Medtronic acquired Covidien for $50 billion. Medtronic says that the HawkOne can treat calcified lesions more than twice as effectively as its prior generation TurboHawk directional atherectomy device. The company pointed to a study published in the Journal of the American College of Cardiology, Cardiovascular Interventions, that showed directional atherectomy had a 95 percent limb salvage in patients with critical limb ischemia and 78 percent effectiveness in keeping treated arteries open in patients at 12 months. Directional atherectomy devices enter the body through a catheter and use a directional cutter that can be positioned within the diseased vessel for optimal performance and increase in blood flow. “Based on physician feedback and collaboration, we have developed a technology that enables physicians to treat lower extremity PAD (or peripheral artery disease) more efficiently and effectively,” said Brian Verrier, the vice “The HawkOne system enhances our directional atherectomy platforms and reinforces our commitment to therapy innovation by providing physicians and patients with new treatment solutions that protect limbs and enhance lives.” PAD affects more than 10 million people in the United States and 202 million people across the globe, Medtronic spokesmen say. It can cause severe pain, limited physical mobility, amputation, cardiovascular disease and even death.

(Gore designed iliac branch and internal iliac components) intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, has been included on the Australian Register of Therapeutic Goods. The first patient procedures in Australia were successfully completed by vascular surgeons Dr. Steven Dubenec, head of department of vascular surgery at Royal Prince Alfred Hospital in Sydney, and Dr. Jack Loa, at Macquarie University Hospital in Sydney. This new device — used in conjunction with GORE EXCLUDER AAA Endoprosthesis components to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries — is built on Gore’s proven technology platform and designed using the same durable, expanded polytetrafluoroethylene (ePTFE) graft. “Based on the design of the GORE EXCLUDER device, this system provides a wide treatment range and long-term durability, which is extremely important for optimal clinical success,” Dr. Dubenec said. “The precannulated branch and bi-femoral delivery elements of the EXCLUDER Iliac Branch Endoprosthesis support the ease of use of this device.” The EXCLUDER Iliac Branch Endoprosthesis system provides a treatment range of 6.5-13.5mm for the internal iliac arteries, and a treatment range of 6.5-25mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a 12 Fr flexible, reinforced introducer sheath for the internal iliac component. VT N READ MORE: goremedical.com

JUNE/JULY 2015 < VEIN THERAPY NEWS

PRODUCTNEWS New SIGVARIS brand video raises public awareness of leg health In an all-new brand campaign video, both patients and SIGVARIS employees take a look back at how the SIGVARIS brand has affected the lives of so many. Generating buzz worldwide, this new campaign video is getting people to talk about their legs and is raising awareness about how a simple change of socks can help people live a more healthy and active lifestyle. “Ninety percent of the population starts showing signs of venous deficiency in early adulthood, and SIGVARIS’ newest brand campaign is designed to raise much needed awareness about the importance of overall leg health,” says Judith Brannan, associate director of education and medical affairs at SIGVARIS North America. The SIGVARIS video addresses common leg problems, including varicose veins and leg pain at work, as well as medical conditions such as deep vein thrombosis (DVT) and diabetes. Real people also discuss how they keep their legs healthy during athletic activities, pregnancy and while traveling. “Many people think it’s normal to have tired, achy legs, or they think varicose veins are just a fact of life because their mother or grandmother had them. The great thing about this new video is that people can hear directly from real patients who have had similar experiences. The video encourages every person to speak with his or her doctor about leg health,” Brannan adds. To watch the video see: http://bit.ly/ SIGmevfl. VT N

Hansen Magellan catheter gets CE

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Hansen Medical’s 10-French Magellan robot-assisted catheter for peripheral artery disease treatment has received CE Mark approval. It boasts the largest inner lumen of any in the Magellan catheter line, according to the Mountain View, Calif., device maker. The catheter is to be used in combination with the company’s Magellan surgery platform, which traverses peripheral blood vessels during endovascular surgeries. The system features guidewire steering and allows for the manual delivery of therapy. Health professionals may perform Magellan procedures remotely, safely away from radiation, the company claims. Last year, Hansen’s 6-French Magellan catheter received FDA 510(k) clearance. VT N READ MORE: hansenmedical.com

VEIN THERAPY NEWS < JUNE/JULY 2015

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PRODUCTNEWS 2015 PVD pipeline report available Research and Markets has announced the addition of the “Peripheral Vascular Disease Pipeline Highlights - 2015” report to its offering. The latest report provides the most up-todate information on key pipeline molecules in the global peripheral vascular disease market. It covers emerging therapies for peripheral vascular disease in active clinical development stages, including early and late stage clinical trials. The pipeline data presented in this report helps executives for tracking competition, identifying partners, evaluating opportunities, formulating business development strategies, and executing in-licensing and out-licensing deals. The clinical trial stages report provides peripheral vascular disease pipeline molecules by clinical trial stages including both early and late stage development: phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research and discovery stage. The drug mechanisms report provides peripheral vascular disease pipeline molecules by their dominant mechanism of action. This helps executives categorize molecules

based on their drug class and also assess the strengths and weaknesses of compounds. The report provides peripheral vascular disease pipeline molecules by the originator company, and lists which pipeline products will be launched in the United States until 2017. VT N READ MORE: researchandmarkets.com /research/cdnbmc/ peripheral STREAMLINEMD

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• Software Enhancements: St rea m lineMD sof t wa re (Streamline PM+ and Streamline EHR) includes ICD-10 functionality and successfully passed all claims submission tests with CMS. Client Software Training: In preparation for the Oct. 1 ICD-10 extended deadline, StreamlineMD began publishing software training to its clients that use Streamline PM+ and Streamline EHR, regarding the new functions of ICD-10, beginning April 1 and continuing through Sept. 30. VT N READ MORE: streamlinemd.com/ehr.aspx

FDA approves Suneva’s Bellafill for acne scars The U.S. Food and Drug Administration (FDA) has approved the Suneva Medical Inc. dermal filler, Bellafill, for the treatment of acne scars. Spokesmen say Bellafill represents a significant clinical advancement as the only filler on the market approved for this disfiguring skin condition. Acne is the most common skin disorder in the United States, affecting 40-50 million people, and up to 95 percent of people with acne may go on to suffer from scarring. Bellafill is safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21. “These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence,” said Nicholas L. Teti Jr., chairman and CEO at Suneva Medical.

The Dec. 23,2014, FDA approval of Bellafill was based on the outcomes of a double-blinded, randomized, placebo-controlled pivotal study in which subjects were treated with Bellafill at 10 U.S. clinical centers. Bellafill was found to be a safe and effective treatment when compared to subjects treated with a Control saline injection. The study required a high threshold for success in which the primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to Control at 6 months. A responder was defined as a subject who had 50 percent or more of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). At 6 months, the response rate for Bellafill was 64 percent vs. 33 percent for Control (p=.0005). Bellafill contin-

In the dermatology field, we regularly see patients who live with the burden of acne scarring — a physical and emotional burden that leads many to feel depressed, less energetic and less social. “The results of this rigorous clinical study prove that Bellafill reduces the appearance of acne scars — providing a solution to this widespread skin condition that previously had limited treatment choices.” In an independent study, more than 70 percent of respondents felt their acne scars negatively affected their self-confidence, with 92 percent indicating self-confidence would be restored or improved if their acne scars were healed. To help treat disfiguring acne scars, Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. The long-lasting treatment is a simple, in-office procedure with minimal to no downtime. “In the dermatology field, we regularly see patients who live with the burden of acne scarring — a physical and emotional burden that leads many to feel depressed, less energetic and less social,” said Dr. Ava Shamban, assistant clinical professor of dermatology at UCLA, and an investigator in the Bellafill acne scar study. “With Bellafill, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life. The level of acne scar correction Bellafill achieves is truly impressive and I greatly look forward to using this proven treatment option with patients.”

STUDY RESULTS

ued to show effectiveness by an unblinded assessment at 12 months (71 percent). Secondary effectiveness endpoints were evaluated, where both investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through 6 months and unblinded at 12 months. Both groups rated appearance as improved, reaching statistical significance at every timepoint after the touch-up period (at week 4) through 6 months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 84 percent of subjects were rated as improved at 6 months and 98 percent were improved at 12 months by an unblinded assessment. On the Subject Global Aesthetic Improvement Scale (SGAIS), 77 percent of subjects rated their appearance as improved at 6 months and 83 percent rated their appearance as improved at 12 months. In addition, subjects were asked to rate their level of satisfaction with acne scar correction treatment on a Subject Assessment of Scar Correction scale (SASC). At 6 months (blinded), 84 percent of subjects were satisfied while 90 percent were satisfied at 12 months (unblinded). VT N READ MORE: sunevamedical.com

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