Conditional IDE approval for Flexstent Femoropopliteal Self Expanding Stent System

Sep 29 2009

Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial and biliary stents, announced today that it has received Conditional Investigational Device Exemption (IDE) approval for its FlexStent^® Femoropopliteal Self Expanding Stent System. With this approval, FSS is initially authorized to begin its US clinical trial at up to 10 clinical sites and 50 patients. FSS expects to address FDA conditions within the next 45 days.

The US clinical trial will be led by Principle Investigator Dr. William Gray. Dr. Gray is the Director of Endovascular Intervention at NY Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy. He will be presenting FSS’s interim OUS six month clinical data at VIVA in Las Vegas, NV next month.

FSS believes that this next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment. The fully connected flexible FlexStent^® provides an atraumatic, highly durable, fatigue resistant stent. It has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist. Janet Burpee, FSS’s CEO commented, “We believe our device could provide the physicians a viable solution for treatment of long, difficult, and diffuse lesions in the femoropopliteal arteries. We are happy to have the opportunity to work with Dr. Gray, and needless to say are very excited about receiving this conditional IDE approval from the FDA.”

The company previously announced that it has received FDA 510(k) clearance for the Biliary FlexStent^® system, and CE Mark authorization for the Biliary and Femoropopliteal FlexStent^® systems.