NOORDWIJKERHOUT, Netherlands and WEBSTER, Texas, May 17, 2011 /PRNewswire/ -- IDEV Technologies announced today that data from a long lesion study of 182 patients with significantly diseased superficial femoral arteries and popliteal arteries showed high patency rates and no stent fractures after treatment with the SUPERA VERITAS® Peripheral Vascular Stent System. The data were presented at the Vaatdagen 2011 (Vascular Days) Conference based on analysis by Andre Molenaar, M.D. and Peter Haarbrink, M.D., interventional radiologists at Canisius-Wilhelmina Ziekenhuis (CWZ) hospital, a leading teaching and high volume medical center in Nijmegen, Netherlands.
The patients were treated and followed over a two year period, and represented an extremely challenging patient cohort with highly calcified and long lesions in the superficial femoral artery (SFA) which at times encompassed the proximal popliteal artery and/or popliteal artery alone. What makes these results extraordinary was that they were achieved in vessels with significant disease and atypical extremely long lesion lengths with no Plavix® used.
The SFA plus proximal popliteal treated artery cohort consisted of 159 patients, with an average lesion length of 240mm, 40% Tasc D classification, and 57% total occlusions with an average of nearly 2 stents per patient. A high patency rate of 74% was achieved at 12 months as measured by Duplex Ultrasound (DU). A group of 23 patients were treated with a SUPERA stent in the popliteal artery, with an average stent length of 142mm and a patency rate of 83% at 12 months, again measured by DU. A subgroup analysis by x-ray at 24 months showed no stent fractures. These data compare favorably to standard nitinol stent performance in patients with significantly shorter lesions.
"These are outstanding and noteworthy results which demonstrate that SUPERA is a market changing technology when used appropriately," stated Dr. Molenaar. "The average stent length deployed was 240mm, ranging from 40mm to 550mm. Compared with other stent trials, and even the Leipzig SUPERA registry, these are much longer lesions with significant disease," added Dr. Haarbrink.
Dr. Molenaar added that no concomitant treatment occurred with antiplatelet medication. "Patients received aspirin post procedure but none of these patients received Plavix® following their stent procedures. We can assume the results would have had an even more dramatic improvement from baseline had we supplemented our procedure with this treatment. It is also clear to us that we utilize SUPERA for the most challenging cases, constantly testing the device and still receive exceptional results. We look forward to continuing our analysis of SUPERA."
Christopher M. Owens, President and CEO of IDEV Technologies, Inc., commented, "We are pleased to see clinicians continue to independently evaluate the SUPERA stent in highly diseased patients. These extremely positive results reflect what we see on a continual basis in the marketplace."
About Canisius-Wilhelmina Ziekenhuis (CWZ)
CWZ is one of the top clinical training hospitals in the Netherlands, with over 650 beds and 31 medical specialties. For more information please visit www.cwz.nl.
About IDEV Technologies, Incorporated
IDEV 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 Europe, Canada and Australia for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
Vice President Global Marketing
IDEV Technologies, Incorporated
SOURCE IDEV Technologies, Incorporated