Flexible Stenting Solutions, a developer of peripheral arterial, venous, neurovascular and biliary stents, has received full FDA Investigational Device Exemption (IDE) approval for its FlexStent Femoropopliteal Self Expanding Stent System.
With the approval, FSS is authorized to begin full enrollment for the OPEN Trial, to evaluate safety and efficacy of the FlexStent Femoro-pOPliteal Self-Expanding StENt System.
The OPEN trial is a prospective, single-arm trial enrolling up to 227 patients at up to 40 US clinical sites and is set to begin in Q1 2011, led by study principal investigator William Gray.
FSS believes that the femoropopliteal stent and delivery system can improve patient care in the high growth peripheral vascular segment.
The FlexStent provides an atraumatic, highly durable, fatigue resistant stent. FSS focused on physician requests for a flexible, durable, conformable and easy-to-deliver stent.
FSS CEO and co-inventor of the FlexStent technology Janet Burpee said the primary goal of a stent is to atraumatically keep a vessel open.
"The high radial strength, and equally important, the construction and accurate deliverability offers a stenting solution which maximizes scaffolding for the vessel while allowing the vessel to naturally move with the bodies motion," Burpee said.