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Atrium Announces the Publication of the COBEST Trial by the Journal of Vascular Surgery
Date:9/29/2011

HUDSON, N.H., Sept. 29, 2011 /PRNewswire/ -- Atrium Medical Corporation today announced the publication of the COBEST Trial by the Journal of Vascular Surgery.  COBEST (Covered Versus Balloon Expandable Stent Trial) was an independent, landmark, prospective, multi center, randomized, controlled clinical trial that has demonstrated that Atrium's proprietary balloon expandable covered stent technology is superior to traditional bare metal stents for the treatment of aorto-iliac disease.  The journal article, "A comparison of covered vs bare metal stents for the treatment of aorto-iliac occlusive disease" is currently in press and is also available on-line at the publisher's websites, www.elsevier.com or www.sciencedirect.com .

COBEST was the first prospective head-to-head comparison of Atrium's Vascular V12 balloon expandable covered stent versus bare metal stents (BMS) for the treatment of a specific type of Peripheral Arterial Disease (PAD) known as aorto-iliac occlusive disease.  The study's principal investigator, Professor Patrice Mwipatayi, M.D., is head of vascular surgery at Royal Perth Hospital in Perth, Australia.

COBEST has demonstrated that in TASC B, C, and D iliac lesions, patients implanted with Atrium's Advanta V12 were more likely to remain free from binary restenosis and had fewer reinterventions than patients with bare metal stents implanted.  Upon sub-analysis, Dr. Mwipatayi and the other co-investigators have concluded that Atrium's Vascular V12 demonstrated the greatest benefit in patients with more complex disease (TASC C & D lesions).  There were significantly lower restenosis rates, significantly lower target vessel revascularization (TVR) rates, significantly improved ABI's, and, when these more difficult TASC C & D lesions were analyzed, lower occlusion rates were observed at twelve and eighteen months compared to BMS.  

In this study, Atrium's Vascular V12 has demonstrated higher long term patency and improved clinical outcomes compared to BMS.  COBEST was an independent investigator initiated study; Atrium Medical had no role in the study design, data collection, data interpretation, or writing of the clinical report.  Atrium provided funding for the study, including the employment of a research assistant.

Dr. Mwipatayi has provided this statement regarding COBEST: "This was the first prospective, randomized, multi center, controlled trial comparing balloon expandable covered stents directly to bare metal stents.  One striking result from the COBEST study was the 5 times lower TVR rate with Atrium's V12 compared to BMS.  This poses a tremendous global economic benefit along with a tremendous quality of life benefit for our patients who are being treated for peripheral vascular disease and more specifically aorto-iliac disease."

About Atrium's Advanta™ V12 covered stent

The Advanta™ Vascular V12 covered stent is a low profile, pre-mounted covered stent made of a radial expandable stainless steel that is completely encapsulated with Atrium's patented one-piece covering technology.  Atrium's patented covering technology creates a thermoconformable microporous PTFE layer that completely encapsulates the stainless steel stent.

Covered stents have been shown to exclude plaque and endothelium, thereby potentially mitigating late luminal loss by halting migration and proliferation of vascular smooth muscle cells and inflammatory cells through open stent struts thus leading to a reduction in restenosis and occlusion rates.  With over 125 clinical publications and over 100,000 patients successfully treated worldwide, this latest publication adds to the rapidly growing body of evidence supporting the safety and efficacy of Atrium's covered stent technology.  The V12 covered stent is CE approved for restoring the patency of iliac and renal vessels and is available in diameters of 5mm to 16mm. The Advanta™ V12 covered stent is not available in the United States.    http://www.atriummed.com/AdvantaV12

About Peripheral Arterial Disease (PAD)

Peripheral Arterial Disease affects over 100 Million people worldwide.  Patients with PAD typically present with symptoms known as claudication or rest pain.  Claudication is severe pain and discomfort or cramping in the legs that occurs when walking or exercising.  Rest pain is defined as "continued pain" or "painful cramping" of the legs immediately following exercise or when a patient is resting.  This lower extremity leg pain is often caused by decreased blood flow to areas of the leg caused by a narrowing of major blood vessels, often as a result of atherosclerosis (build-up of plaque and cholesterol) along the luminal walls of peripheral arteries, including the iliac, femoral and popliteal vessels.

About Atrium Medical

Atrium's vast expertise in medical device technologies for the treatment of vascular and coronary disease, chest trauma, hernia and soft tissue injury has brought a number of breakthrough advances in several diversified healthcare markets. Maintaining a commitment to the latest ISO 13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced minimally invasive and surgical intervention options for improvements in patient outcomes. For more information please call Atrium's Marketing Communications Department at 1-800-370-7899 or visit us on the web at www.atriummed.com .


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