Oct 24 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 Dr. William Gray of NY 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 Dr. Dierk Scheinert 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 1, 6 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 6 and 12 month visits using standard x-ray evaluation methods.
The pooled clinical results from the Auckland and Leipzig sites were 92.3% patency and a 0% 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%.
Dr. Holden stated, “We are pleased with the favorable clinical results of the FlexStent® to date and its positive impact on our patients.” FSS’s CEO, Janet Burpee added, “These interim results are extremely encouraging for the long term success of this next generation self expanding stent.”
The FlexStent® US clinical trial, led by Principle Investigator Dr. William Gray, Director of Endovascular Intervention at NY Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy, will commence in early 2010.
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