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IDEV's Pivotal SUPERB Trial Demonstrates SUPERA® Stent Significantly Exceeds VIVA Criteria for One-Year Patency in Femoropopliteal Artery Disease PR Newswire LAS VEGAS and WEBSTER, Texas, Oct. 11, 2012 -- Late-Breaking Data Presented at Vascular InterVentional Advances (VIVA) 2012 Conference in Las Vegas -- --Data from SUPERB Trial Support IDEV's PMA Filing with the FDA-- LAS VEGAS and WEBSTER, Texas, Oct. 11, 2012 /PRNewswire/ -- IDEV Technologies, Inc. (IDEV) today announced positive clinical outcomes for its SUPERB pivotal clinical trial of its SUPERA® Peripheral Stent System. This Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial demonstrated the highest patency rates in peripheral stent trials for superficial femoral or proximal popliteal artery disease that has been publically reported. In addition, this is the first and only femoral-popliteal artery IDE trial to record zero stent fractures for nitinol-based technologies. The SUPERA stent is a highly differentiated, disruptive and proprietary interwoven nitinol wire technology platform that offers significantly improved radial strength, flexibility and kink resistance, which is designed to adapt to the anatomy. Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital and study co-principal investigator, presented the 12-month outcomes from SUPERB in the Late Breaking Trials session of the 10th VIVA Conference held in Las Vegas, Nevada.
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