FlexStent Femoropopliteal Stent Receives IDE Approval for Trial
October 1, 2009 – Flexible Stenting Solutions Inc. (FSS) said this week it received conditional investigational device exemption (IDE) approval from the FDA for its FlexStent Femoropopliteal Self-Expanding Stent System so it can begin its U.S. clinical trial at up to 10 clinical sites and with 50 patients.
The U.S. clinical trial will be 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. He will be presenting FSS’s interim OUS six month clinical data in October at VIVA in Las Vegas, NV.
FSS believes 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. The company believes its device could provide the physicians a viable solution for treatment of long, difficult, and diffuse lesions in the femoropopliteal arteries.
The company has received CE mark in Europe for its Biliary and Femoropopliteal FlexStent systems.
For more information: www.flexiblestent.com
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