January 22, 2009 - Flexible Stenting Solutions Inc. said this week it received CE Mark for its FlexStent Femoropopliteal Self Expanding Stent System.
Stent sizes include a complete matrix of 5, 6, 7 and 8 mm diameters with 30 through 150 mm lengths in a 6 French delivery system.
The FlexStent Femoropopliteal Self Expanding Stent System is indicated for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries. The company developed a novel, self-expanding stent technology to provide a wide range of vascular and non-vascular therapies. The fully connected flexible FlexStent has coupled technology with clinical needs by providing a stent with superior durability, flexibility, and radial stiffness, while providing uniform scaffolding. The key to the stent technology is the integration of helically wound struts with helical flexible coils. The key to the delivery system technology is simplicity, ease-of-use and placement, the company said.
In addition to the CE Mark, FSS plans to submit an investigational device exemption (IDE) application to the FDA. IDE approval will allow FSS to commence a U.S. clinical trial to collect clinical data for FDA premarket approval.
For more information: www.flexiblestent.com