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SIGVARIS DETAILS NEW PHOTO CONTEST

One of the biggest compliments a SIGVARIS spokesperson says it gets as a company is when someone puts on SIGVARIS socks or hosiery and says his or her legs instantly feel better. Based on this feedback, SIGVARIS has launched a photo contest as an important step in raising awareness and improving leg health across America.

Market Analyst and Communications Manager Melissa Gwozdz said that over the next few months, the company is asking fans of SIGVARIS to “Show Us How SIGVARIS Makes Your Legs Feel.” The person with the most creative photo will be awarded $1,000. Other top voted photos will win free products from SIGVARIS.

Around a third of all people between 18 and 79 suffer from leg swelling and varicose veins, and most leg problems don’t just surface overnight. Early symptoms include heavy, tired or achy legs, a feeling of cramps or fatigue in the legs, swollen ankles, spider veins and/or varicose veins.

SIGVARIS products were created to aid in the prevention of chronic venous problems. Socks and hosiery that feature graduated compression are designed to be tightest at the ankle and decrease in pressure going up the legs. Graduated Compression garments help improve circulation and revive tired, achy legs. They also help with the treatment and prevention of varicose veins.

Gwozdz said SIGVARIS offers three categories of products: SIGVARIS MEDICAL, SIGVARIS WELL BEING and SIGVARIS SPORTS. S”IGVARIS offers fashionable compression options designed to fit any lifestyle.

To enter the contest post a creative photo on Facebook or Twitter “Showing Us How SIGVARIS Makes Your Legs Feel” with the hashtag #MySIGVARIS. Photos must be submitted by Dec. 31. Voting for the best photo will take place in January, and a link to vote will be placed on the SIGVARIS USA Facebook and Twitter pages. READ MORE: http://bit.ly/MySIGVARISPhotoRules or www.sigvarisusa.com

AVVI ADDS STAFF DEVELOPMENT, LEADERSHIP HIRE

Brenda Blanchard-Kooser has been hired as American Vein & Vascular Institute (AVVI) vice president of organizational services, a position that brings an increased focus on company culture.

She is responsible for staff development and leadership, communication services and internal human resources. She will serve as AVVI's direct liaison with Insperity, the professional employer organization that is also her previous employer.

"I am delighted and honored to be given this new opportunity," says Blanchard-Kooser. "I look forward to getting to know the entire AVVI team, and to helping improve company-wide collaboration and communication - while also contributing to the organization's ability to provide expert patient care."

AVVI CEO Erin Gibbs said that Blanchard-Kooser is a seasoned professional who brings just as much industry experience as she does vibrant personality. "There is no doubt that the fun factor at AVVI just went up a notch with her coming aboard. It goes without saying that she is fully equipped to run an entire department. We are thrilled to be able to call her a part of our team."

CYNOSURE ACQUIRES ELLMAN INTERNATIONAL

The assets of Ellman International Inc have been acquired by Cynosure Inc. for approximately $13.2 million in cash. The transaction is expected to be accretive to Cynosure’s earnings per share by the first quarter of 2015.

Ellman’s current annualized revenue run-rate is approximately $25 million.

Ellman, which annualized revenue-rate is about $25 million, develops, manufactures and markets advanced radiofrequency (RF) technology for precision surgical and aesthetic procedures, and offers a line of aesthetic lasers. Ellman’s product line includes the Pellevé Wrinkle Reduction System, PelleFirm RF Body Treatment System and the Surgitron Surgical RF Systems.

Cynosure’s product portfolio comprises a range of energy sources, including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, and Q-switched lasers, and intense pulsed light including Cellulaze, SmartLipo, and Picosure.

STUDY SHOWS DIRECTIONAL ATHERECTOMY
SAFE AS FRONTLINE THERAPY FOR P.A.D.

Directional atherectomy is safe and effective as a frontline therapy for the treatment of peripheral arterial disease (P.A.D.), according to a landmark Covidien study published online Aug. 18 in the Journal of American College of Cardiology, Cardiovascular Interventions (JACC CI).

Results from the DEFINITIVE LE study using Covidien’s TurboHawk and/or SilverHawk directional atherectomy systems demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months. The DEFINITIVE LE study is the largest atherectomy study conducted to date with independent, core lab analysis of the clinical outcomes.

“The DEFINITIVE LE study provides confirmatory evidence based on 12-month, independent core lab adjudicated data on the use of directional atherectomy in treating a diverse, real-world group of patients with P.A.D.,” said James F. McKinsey, MD. FACS, co-global principal investigator and lead author of the study.

“The study enrolled 800 patients, making it the largest trial with independent, core lab analysis for atherectomy to date. Results of the study demonstrate high limb salvage, patency rates and diabetic outcomes. This further confirms the effectiveness and versatility of directional atherectomy in a range of vessel sizes and clinical presentations. Atherectomy is an important treatment option as the therapy leaves nothing behind in the body and preserves all future treatment options.”

More than 10 million people in the United States are affected by P.A.D.,1 one of the most common vascular diseases occurring when arteries in the legs become narrowed or blocked by plaque. These blockages can result in severe pain for patients, limited physical mobility and non-healing leg ulcers.

Additionally, P.A.D. can have serious health consequences, including amputation and death. In fact, more than one million people in the United States are living with a limb loss as a result of diabetes and P.A.D.,2 and nearly half of the individuals who have an amputation due to vascular disease will die within five years.3 The prospective, multi-center DEFINITIVE LE study enrolled 800 patients in 47 centers in the United States and Europe and included two patient cohorts: those with claudication and those with CLI.

Patients enrolled in the study were treated with the TurboHawk and/or SilverHawk, a catheter-based, minimally invasive treatment to remove plaque and restore blood flow, without leaving anything behind in patients with P.A.D. For the first time in an atherectomy study, DEFINITIVE LE also included pre-specified sub-group analysis comparing patency rates in diabetic and non-diabetic patients.

“The outcomes for patients with claudication reveal that in the scientific landscape directional atherectomy is not only safe, but effective to a similar degree as previous trials in the superficial femoral artery (SFA),” said Dr. Lawrence Garcia, co-global principal investigator of the study and chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth’s Medical Center in Boston. “Diabetic patients, who remain challenging for therapy due to their advanced and multi-level disease, have similar patency rates to non-diabetic patients with claudication when performing directional atherectomy. These findings provide strong clinical support for the versatility of directional atherectomy in treating patients with diabetes, claudication and critical limb ischemia.”

Among patients with claudication, primary patency was 78 percent at 12 months. Notably, this rate did not differ between patients with diabetes (77 percent) and those without diabetes (78 percent) — the first such results to be shown in a prospective, powered analysis. Specifically for the SFA, the patency rates were 83 percent in lesions under 10cms in the claudicant cohort.

DEFINITIVE LE is the largest study of a series of three studies, which includes DEFINITIVE Ca++ and DEFINITIVE AR. The DEFINITIVE series enrolled 1,054 patients in the U.S. and Europe to evaluate the effectiveness of directional atherectomy.

Mark A. Turco, MD, chief medical officer of vascular therapies at Covidien, said that what makes Covidien unique as a leader in the peripheral vascular field is commitment to advancing scientific research. “The publication of DEFINITIVE LE in JACC CI represents an important milestone in our DEFINITIVE clinical series. We continue to invest in the DEFINITIVE clinical programs to deliver the best clinical evidence and treatments for patients suffering with P.A.D.”

RESOURCES

  1. Peripheral Artery Disease. The Society for Cardiovascular Angiography and Interventions. http://www.scai.org/SecondsCount/Disease/PeripheralArteryDiseasePAD.aspx
  2. Ziegler, Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation 2008;89(3):422-9.
  3. Robbins JM, Strauss G, Aron D, Long J, Kuba J, Kaplan Y. Mortality Rates and Diabetic Foot Ulcers. Journal of the American Podiatric Medical Association 2008;98(6):489‐93.


PARK SWORN-IN AS NEW AAFPRS
PRESIDENT; WILLIAMS IS PRESIDENT-ELECT

Stephen S. Park, MD, FACS, is the new president of the American Academy of Facial Plastic and Reconstructive Surgery. He was sworn-in during the Academy’s annual Fall Meeting in Orlando, Fla. Dr Park is also the vice-chairman of the Department of Otolaryngology-Head & Neck Surgery at the University of Virginia in Charlottesville.

“It is an honor to be elected as president of the American Academy of Facial Plastic and Reconstructive Surgery by my peers,” Park said. “I hope to continue the mission of outgoing president Dr Edward Farrior —I n particular, his heroic efforts in bringing better standardization and recognition to our fellowship programs. Education and preparation for the future generations of facial plastic surgeons is the highest priority for this term, and I hope to emphasize the importance of staying true to our roots and serving the public.”

Edwin F. Williams, III, MD, is the president-elect for the 2014-2015 term. Currently the Group VP for Public and Regulatory Affairs for the AAFPRS, Dr Williams is a board-certified facial plastic surgeon and founder of Williams Center Plastic Surgery Specialists in Albany, N.Y.

TUMMY TUCK MAY CURE INCONTINENCE

A patient who had a tummy tuck observed that she no longer had leakage whenr laughing or coughing. During a postabdominoplasty followup visit, she mentioned that to her doctor who became intrigued about this phenomenon and launched a new study. Study author James D. McMahan, MD, a plastic surgeon in Columbus, Ohio, said there was very little in the literature about the phenomenon. What they learned was that relief from stress urinary incontinence may be an additive benefit following abdominoplasty. The results were presented in the September issue of the “It’s always a good idea to listen to your patients,” Dr. McMahan told Plastic Surgery Practice.

Dr. McMahan and his researchers studied postoperative changes in 250 women with stress urinary incontinence who underwent cosmetic abdominoplasty. Patients were subgrouped according to postoperative changes in their urinary incontinence symptoms, and the subgroups were then evaluated for common within-group characteristics. Of the 250 patients who underwent abdominoplasty in the study, 40 percent completed the survey, half of whom reported incontinence preoperatively. After abdominoplasty, 60 percent of these patients noted improvement in their symptoms, and the other 40 percent reported no improvement. Lack of previous Cesarean section was a predictor of improvement in stress urinary incontinence symptoms after abdominoplasty.

No one knows exactly how or why the surgery improves urinary incontinence is not fully understood, but theories exist. For example, “in some of the abdominoplasty procedures where we pull up on the skin, we may get enough of a pull on the urethra to reduce hypermobility and incontinence,” Dr. McMahan said. “The next step may be an urodynamic study to further delineate who can expect this improvement following a tummy tuck.

“If we could better identify who would benefit in advance, and they are considering having a procedure to treat incontinence and a tummy tuck, it may behoove them to have the tummy tuck first and see what happens."

CMS CLARIFIES CDS ALERTS
WITH TIP SHEET, FAQ

The Centers for Medicare & Medicaid Services (CMS), bothered by some of the negative outcomes involving intrusive pop-up clinical decision support (CDS) alerts, has issued a tip sheet and answers a FAQ to clarify that the Meaningful Use (MU) incentive program is not limited to just this type of notification.

“The CDS is a key functionality of health information technology that—when effectively applied— contributes to increased quality of care and enhanced health outcomes, error and adverse event avoidance, improved efficiency, reduced costs, and enhanced provider and patient satisfaction,” the CMS Tip Sheet states. “Recognizing this potential to improve care, Congress included CDS as a centerpiece of the Medicare and Medicaid EHR Incentive Programs.”

In Stage 1, CMS says providers must implement one CDS rule. In Stage 2 providers must implement five CDS interventions and enable and implement functionality for drug/drug and drug/allergy interaction. But the program does not require pop-up notifications.

The CDS, according to CMS, "is not simply an alert, notification, or explicit care suggestion." It adds that providers can meet the program's objective via other kinds of CDS, including clinical guidelines, condition-specific order sets, focused patient data reports and summaries and diagnostic support, among other options. CDS interventions apply to doctors or nurses, patients and other caregivers, according to CMS.

The CMS' tip sheet clarifies the function of CDS further, stating that such interventions must provide the right information -- including evidence-based guidance and response to clinical need -- "to the right people, through the right channels, in the right intervention formats and at the right points in workflow."

The tip sheet is here and the new FAQ is at www.questions.cms.gov/faq.php?id=5005&faqId=10228.

OBAMA ADMINISTRATION’S TAX INVERSION
REFORMS HAS MEDTRONIC RECONSIDERING

Treasury Secretary Jacob Lew has unveiled reforms to make tax inversion more difficult and less attractive, potentially killing some pending mergers with foreign companies, including Medtronic's $43 billion acquisition with Ireland's Covidien.

According to Minneapolis-based Medtronic, one of the major benefits was easier access to its foreign earnings and nearly $14 billion stockpile of overseas cash and cash equivalents. To accomplish that, the company planned a hopscotch loan to its new Irish parent company, Medtronic PLC. But that attraction is diminished by the reform's ban on hopscotch loans, by which companies could access their foreign subsidiary's earnings while deferring U.S. taxes.

"For some companies considering mergers, today's action will mean that inversions no longer make economic sense," Lew said in a statement. No one knows yet if the the Medtronic-Covidien deal is among them.

The two companies' agreement allows for Medtronic to cancel the deal without penalty in the case of changes to U.S. tax laws.

Medtronic told FierceMedicalDevices in an email that the company is studying the Treasury's actions and will release its "perspective on any potential impact on our pending acquisition of Covidien following our complete review."

The other reforms prevent companies from restructuring a foreign subsidiary to access its earnings tax-free, prevent the tax repatriation of cash or property to the U.S., and make it more difficult for a foreign company to surpass the 20 percent ownership threshold that triggers inversions. The reforms are not retroactive and only apply to deals that will close in the future.

The largest deal, between Big Pharma companies AbbVie and Ireland's Covidien, is also threatened. The $43 billion proposed merger between Medtronic and Covidien would be the second largest inversion deal since the failed marriage between Pfizer and the U.K.'s AstraZeneca unleashed a wave of inversion deals in the healthcare arena.

Political pressure led drug store Walgreens to cancel the inversion element of its merger with the U.K.'s Alliance Boots, and now a tighter squeeze of the fist from government could undo the rest.

Companies tried to sell the inversion deals to a skeptical public and politicians. Medtronic CEO Omar Ishrak promised the new company would invest an additional $10 billion in the U.S. over the next decade. But 68 percent of Minnesota residents still say companies should not be allowed to move to obtain tax benefits, according to a recent Minneapolis StarTribune poll (including a majority of Republicans).

Ishrak's statement was overshadowed by his company's decision to a cover a special tax bill for 15 executives and 10 company directors at a cost of $63 million, including $24.8 million in special taxes for the CEO himself. The special tax was a result of a 2004 law that imposes a 15 percent tax on stock and option awards to top executives of companies seeking tax inversion deals--a reflection of the government's longtime dislike of inversion, and an example of companies' moves to navigate around disincentives to the practice.

Ordinary shareholders disliked picking up the tab for the tax bill. They also heckled Ishrak at Medtronic's annual shareholder meeting because (assuming the deal goes through) they will face hefty capital gains taxes upon the sale of their old stock in return for shares of the new Irish company Medtronic PLC. Still, the company's stock is was up slightly since the merger was announced, but has fallen a little more than 2 percent, back to its pre-announcement level. VTN

Featured Contributor



Dr. Melanie Petro Melanie L. Petro, MD, ABOto, RPhS, and a partner of the late Dr. John Kingsley, at Petro Cosmetic Surgery and the Alabama Vascular & Vein Center in Birmingham, Ala. She is a member of the editorial advisory boards of Vein Therapy News and Aesthetics News Today.

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