LEIPZIG, Germany, Feb. 8, 2011 /PRNewswire/ -- Data from the Leipzig Registry tracking the results of patients treated with the SUPERA® stent for peripheral arterial disease (PAD) of the popliteal artery were reported during the recent 2011 Leipzig Interventional Course (LINC). The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe. In the United States the SUPERA stent is the subject of an ongoing FDA-approved IDE trial called SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) for treatment of PAD of the superficial femoral artery (SFA).
Dr. Andrej Schmidt of the Department of Angiology at Park Hospital and Heart Center in Leipzig presented the 12-month European data. The 101 patients treated at Park Hospital had advanced PAD. Nearly a third of the patients were classified as Rutherford 4 or 5, and almost 50 percent had an occlusion of the popliteal artery. The average stent length within the registry was approximately 8.5 centimeters.
The primary patency rate, measured by duplex ultrasonography, was 87 percent at 12 months. In addition, there were no stent fractures detected by x-ray at an average of 13.3 months.
"The SUPERA stent has become our stent of choice," commented Dr. Schmidt. "No standard nitinol stent provides the same level of flexibility and radial strength, and both characteristics are necessary to conform to and support the SFA and popliteal anatomy."
"SUPERA is a different class of stent, and is exhibiting remarkable long-term durability in extremely diseased patients," commented Richard C. Kovach, M.D. and Chair, Department of Endovascular Medicine and Director, Cardiac Catheterization Laboratory at Deborah Heart and Lung Center in Browns Mills, New Jersey. "There were several presentations and live cases throughout LINC highlighting ho