Flexible Stenting Solutions Files IDE With FDA for FlexStent Femoropopliteal Self-Expanding Stent
March 18, 2009 - Flexible Stenting Solutions Inc. (FSS) this week submitted an investigational device exemption (IDE) application to the FDA for its FlexStent Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries.
The company said this next generation femoropopliteal stent and delivery system may significantly improve patient care in the high growth peripheral vascular segment. While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate stents, which are prone to strut fracture in the legs. The company said its fully connected flexible FlexStent is, flexible, highly durable and fatigue resistant and has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel.
FSS’s principle investigator for the U.S. clinical trial will be Dr. William Gray, the director of endovascular intervention at New York Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy.
“The unique design developed for the FlexStent intends to address the important issue of stent fracture in the demanding femeropopliteal arterial segment, while maintaining radial force,” said Dr. Gray. “I am looking forward to beginning the clinical trial and excited to be part of this endeavor.”
For more information: www.flexiblestent.com