FlexStent Femoropopliteal SE Stent System FIM study results presented at VIVA conference

Nov 10 2010

Final first-in-man (FIM) clinical results on the use of the FlexStent^® Femoropopliteal SE Stent System were presented recently at the VIVA conference in Las Vegas by Dr. Andrew Holden of Auckland City Hospital. The clinical results originated from Flexible Stenting Solutions, Inc.'s (FSS) FIM study conducted in New Zealand by Principle Investigator Dr. Andrew Holden, and FSS's supplementary study conducted in Germany by Principle Investigator Dr. Dierk Scheinert of University of Leipzig - Heart Center.

“The mid-term clinical results of the Flexstent® are encouraging and the resistance to fracture is a strong feature of this stent.”

The primary objective at both sites was to evaluate the safety and efficacy of the FlexStent^® as measured by the Freedom from Major Adverse Cardiac Events (MACE) at 30 days and the absence of in-stent binary restenosis (patency) using duplex ultrasound (DUS) at 1, 6, 12 and 18 (NZ only) month intervals. The patency was determined by a DUS peak systolic velocity ratio (PSVR) ≤ 2.5. The pooled results for all stents 120 mm and shorter were summarized.

The Freedom from MACE was 100% at all visits. The patency at 12 months was 85.2% for an average lesion length of 84 mm. Results at 18 months from New Zealand show promise for continued efficacy. The absence of stent fracture was shown through all visits using standard x-ray evaluation methods.

Dr. Holden stated "The mid-term clinical results of the Flexstent^® are encouraging and the resistance to fracture is a strong feature of this stent." FSS's CEO, Janet Burpee, added "We feel our uniquely fully connected stent offers the atraumatic solution needed in the femoropopliteal arteries, and are very enthusiastic to start our US clinical trial."

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 with full IDE approval. Conditional IDE approval was given by the FDA in September 2009.