Two-Year Data Published for Idev's Supera Stent in Treatment of SFA Disease

December 15, 2011—Idev Technologies, Inc. (Webster, TX) announced that 24-month data on the company's Supera wire interwoven nitinol stent were published by Dierk Scheinert, MD, et al in the Journal of Endovascular Therapy (2011;18:745–752). 

The results are from the Leipzig SUPERA Registry, which studied the use of Supera in patients with peripheral artery disease of the superficial femoral artery (SFA). As reported in Endovascular Today, Sven Braunlich, MD, first presented the data in January during the 2011 Leipzig Interventional Course in Germany.



According to Idev, 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 2 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 total occlusions and heavily calcified lesions. The average lesion length was > 9 cm, with the average stented segment length > 11 cm.


“The results of our analysis showed a 99% procedural success, with a primary patency at 12 months of 85% and at 24 months of 76%,” commented Dr. Scheinert. “Importantly, follow-up radiographs revealed no stent fractures, and clinical assessments of Rutherford-Becker class and ABIs were all statistically, significantly improved at all follow-up intervals.”



The company noted that the Supera stent has received regulatory approval for biliary and peripheral vascular use in Europe, Canada, Australia, and several Asia-Pacific markets. In the United States, the device is cleared for biliary use and is being studied for the treatment of peripheral artery disease of the SFA in an ongoing trial being conducted under an investigational device exemption from the US Food and Drug Administration.