LEIPZIG, Germany, Jan. 26, 2011 /PRNewswire/ -- IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced the release of two-year European data from the prominent Leipzig Registry, which tracks patients treated with the SUPERA wire interwoven nitinol stent. The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe. In the United States, the SUPERA stent is currently being studied in an ongoing FDA approved IDE trial for treatment of peripheral arterial disease of the superficial femoral artery (SFA).
The single-center registry includes data from 107 patients treated for peripheral arterial disease of the SFA. Within the study population, about a third of the patients had occlusions, 17 percent were categorized as Rutherford 4 or 5, and another 82 percent were Rutherford 3. Additionally, half the treated lesions required placement of the SUPERA stent in the distal third of the SFA. These highly diseased patients, with severely calcified lesions, had an average treated lesion length of approximately 11 centimeters, nearly double that in other stent trials.
Results were presented by Sven Braunlich, MD of the Department of Angiology at Park Hospital and Heart Center, Leipzig, Germany during the 2011 Leipzig Interventional Course (LINC). Key data points include a primary patency rate of 76 percent by duplex ultrasonography at two years with no stent fractures. The 12-month patency rate was 85 percent, and the 18-month patency rate was also 76 percent, showing stable patency from 18 to 24 months.
Dr. Braunlich remarked, "The SUPERA stent has been shown in independent testing to be extremely crush and fracture resistant compared to standard nitinol stents. Combined with the flexibility of the interwoven design, it is very well suited for use in the challenging SFA. X-ray