News | October 26, 2009

Results Presented On Use Of FlexStent in the Superficial Femoral Artery

October 27, 2009 – Interim six-month clinical results on the use of the FlexStent Femoropopliteal Self Expanding Stent System in the Superficial Femoral Artery were presented today at the VIVA conference by William Gray, M.D., of New York Columbia-Presbyterian Hospital. The clinical results originated from Flexible Stenting Solutions, Inc (“FSS”) first-in-man study conducted in New Zealand by principle investigator Dr. Andrew Holden of Auckland City Hospital, and FSS’s supplementary study conducted in Germany by principle investigator Dierk Scheinert, M.D., of University of Leipzig – Heart Center.

The primary objective at both sites was to evaluate the safety and efficacy of the FlexStent as measured by the absence of in-stent binary restenosis (patency) using duplex ultrasound (DUS) at one-, six- and 12-month intervals. The primary efficacy endpoint is based on DUS peak systolic velocity ratio (PSVR). Several secondary efficacy endpoints were evaluated. The absence of stent fracture was also evaluated at both sites at the six and 12 month visits using standard X-ray evaluation methods.

The pooled clinical results from the Auckland and Leipzig sites were 92.3 percent patency and a 0 percent fracture rate for an average lesion length of 86.8 mm. Both sites reported only one in-stent stenosis with 13 patients at each site for a total of 26 patients at six months to date. Freedom from major adverse cardiac events (MACE) at both sites was 100 percent.

“We are pleased with the favorable clinical results of the FlexStent to date and its positive impact on our patients,” Dr. Holden said.

The FlexStent U.S. clinical trial, led by principle investigator William Gray, M.D., director of endovascular intervention at New York Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy, will commence in early 2010.

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