Flexible Stenting Solutions, Inc. (“FSS”), a leading developer of next-generation flexible stents, announced today it has received CE Mark (Conformité Européene) 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. FSS has 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 FSS platform 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.
Janet Burpee, FSS’s CEO, stated, “This is a significant milestone for FSS. We have been working diligently in preparation for CE Mark on this system.” She added, “We believe our unique platform technology will provide needed clinical solutions in the interventional radiology, cardiology and gastroenterology device marketplace.”
In addition to the CE Mark, FSS plans to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA). FDA IDE approval will allow FSS to commence a U.S. clinical trial to collect clinical data for FDA Premarket Approval (PMA).
Source: Flexible Stenting Solutions, Inc.