LEIPZIG, Germany, Feb. 8, 2011 /PRNewswire/ -- Data from the Leipzig Registry tracking the results of patients treated with the SUPERA® stent for peripheral arterial disease (PAD) of the popliteal artery were reported during the recent 2011 Leipzig Interventional Course (LINC). The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe. In the United States the SUPERA stent is the subject of an ongoing FDA-approved IDE trial called SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) for treatment of PAD of the superficial femoral artery (SFA).
Dr. Andrej Schmidt of the Department of Angiology at Park Hospital and Heart Center in Leipzig presented the 12-month European data. The 101 patients treated at Park Hospital had advanced PAD. Nearly a third of the patients were classified as Rutherford 4 or 5, and almost 50 percent had an occlusion of the popliteal artery. The average stent length within the registry was approximately 8.5 centimeters.
The primary patency rate, measured by duplex ultrasonography, was 87 percent at 12 months. In addition, there were no stent fractures detected by x-ray at an average of 13.3 months.
"The SUPERA stent has become our stent of choice," commented Dr. Schmidt. "No standard nitinol stent provides the same level of flexibility and radial strength, and both characteristics are necessary to conform to and support the SFA and popliteal anatomy."
"SUPERA is a different class of stent, and is exhibiting remarkable long-term durability in extremely diseased patients," commented Richard C. Kovach, M.D. and Chair, Department of Endovascular Medicine and Director, Cardiac Catheterization Laboratory at Deborah Heart and Lung Center in Browns Mills, New Jersey. "There were several presentations and live cases throughout LINC highlighting how SUPERA is uniquely suited to the femoropopliteal anatomy, indicating it may indeed be a market-changing technology."
D. Christopher Metzger, M.D. is the Director of Cardiac and Peripheral Labs and Medical Director of Clinical Research at Wellmont CVA Heart Institute. He is an investigator in the SUPERB trial, and also on faculty at LINC. He remarked, "This data correlates well with our own experience with the SUPERA stent. I believe we can now confidently stent, knowing that SUPERA will remain physiologically conformable, will not fracture, and will have excellent long-term patency. In my opinion, future trials will confirm that the SUPERA stent will be an excellent front-line therapy for a majority of infra-inguinal endovascular interventions, especially in areas that have typically been a 'no-stent' zone."
Independent mechanical testing reported zero stent fractures for any SUPERA stent assessed after 10 million cycles of 120 degrees flexion and extension and 20 million cycles of torsion. In comparison, all standard nitinol stents tested fractured before 100,000 cycles in the flexion and extension testing and before 1 million cycles in compression load testing. The SUPERA stent was demonstrated to have a minimum of four times the radial strength and 360 percent stronger crush resistance than standard nitinol stents, and completely resisted fracturing, kinking, crushing, and crimping.
"The data from the Leipzig popliteal registry is very promising," observed Christopher Owens, President and CEO of IDEV. "We are very excited about the feedback we are receiving from physicians who have direct experience with the SUPERA stent. The fact that no other stent has been evaluated in the popliteal artery, let alone shown this level of patency, gives us confidence that it's truly a unique device in a growing market."
About IDEV Technologies, IncorporatedIDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery and cardiology. IDEV's worldwide headquarters is located in Webster, Texas and its European headquarters is located in Beuningen, The Netherlands. For more information please visit www.idevmd.com.
The SUPERA stent is currently indicated in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
About the Leipzig Interventional Course (LINC)The Leipzig Interventional Course is committed to advancing the scientific and clinical evaluation and treatment of patients with complex vascular disease through an interdisciplinary discussion of novel endovascular techniques. For more information please visit www.leipzig-interventional-course.com.Contact:
Donna LucchesiVice President Global MarketingIDEV Technologies, Incorporated(281) 525-2000
|SOURCE IDEV Technologies, Incorporated|
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