WEBSTER, Texas, Dec. 15, 2011 /PRNewswire/ -- IDEV Technologies, Inc. today announced the publication of 24-month data on the company's SUPERA® stent. The data was published in the December issue of the Journal of Endovascular Therapy, and includes the results of the Leipzig SUPERA Registry, which studied the use of the SUPERA interwoven nitinol stent in patients with peripheral artery disease of the superficial femoral artery (SFA).
The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe, Canada, Australia and several Asia-Pacific regions. In the United States, the SUPERA stent is cleared for biliary use, and is currently being studied in an ongoing FDA-approved IDE trial for treatment of peripheral artery disease of the SFA.
The single-center registry is a retrospective analysis of 107 patients with atherosclerotic femoropopliteal lesions. All patients were treated with the SUPERA stent, and were followed for up to two years by Doppler ultrasound, radiographic stent examination, and clinical assessments of Rutherford Becker class and ankle brachial index (ABI).
The study population included patients with a variety of complex lesions, including those with total occlusions and heavily calcified lesions. The average lesion length was over 9 centimeters, with the average stented length segment exceeding 11 centimeters.
Dierk Scheinert, MD, is the corresponding author for the study. He commented, "The results of our analysis showed a 99 percent procedural success, with a primary patency at 12 months of 85 percent and at 24 months of 76 percent. Importantly, follow-up radiographs revealed no stent fractures, and clinical assessments of Rutherford-Becker class and ABI were all statistically significantly improved at all follow-up intervals."
Christopher Owens, President and CEO of IDEV, said, "Seeing these results published in a peer-reviewed journal is a significant milestone for the SUPERA technology. The long term patency data, along with the absence of stent fracture, confirms the experience we've observed in clinical settings, and compares favorably to recent data reported on drug eluting stent performance in the SFA."
About The Journal of Endovascular Therapy
The Journal of Endovascular Therapy is an official publication of the International Society of Endovascular Specialists. It publishes peer-reviewed articles of interest to clinicians and researchers in the field of endovascular interventions.
For more information visit www.jevtonline.org.
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.
The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada, Australia and Hong Kong for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
For more information please visit www.idevmd.com.
Vice President Global Marketing
IDEV Technologies, Incorporated
SOURCE IDEV Technologies, Incorporated