LAS VEGAS and WEBSTER, Texas, Oct. 10, 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 10 th VIVA Conference held in Las Vegas, Nevada.
The SUPERB study enrolled 264 patients at 34 centers across the country, treating 266 lesions with a mean length of 8 cm. De novo or restenotic lesions in the superficial femoral and proximal popliteal arteries of 40-140 mm in length were enrolled. Key results included:
- The primary safety endpoint of freedom from death, target lesion revascularization (TLR) or any amputation of the index limb to 30 days post-procedure, was met by 99.6 percent of the patients.
- The study also exceeded the primary efficacy endpoint with a statistically significant improvement over the objective performance goal established by the FDA and VIVA Physicians, Inc. for vessel patency at one year.
- Based on survival analysis, the SUPERA stent achieved freedom from loss of primary patency at one year of 86 percent.
- Freedom from TLR of 90 percent
- Zero reported stent fractures at one year.
"In the SUPERB trial, the SUPERA stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the SFA and proximal popliteal artery," said Dr. Rosenfield. "The unique design of the SUPERA stent and its combination of flexibility and radial strength may account for this stent's ability to restore durable patency."