FDA approves FSS's FlexStent system IDE for OPEN Trial

Feb 2 2011

Flexible Stenting Solutions, Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today that it has received full FDA Investigational Device Exemption (IDE) approval for its FlexStent^® Femoropopliteal Self Expanding Stent System. With this approval, FSS is authorized to begin full enrollment for the OPEN Trial (US Evaluation of 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 U.S. clinical sites. The study is set to begin in Q1 2011 and is being led by Dr. William A. Gray (study Principal Investigator). Dr. Gray is the Director of Endovascular Intervention at NY Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy. Dr. Gray is anxiously looking forward to getting this trial underway. He commented, "This is a major milestone for the Company and in combination with compelling early overseas data affords it the opportunity to further demonstrate the safety and efficacy of the product and ultimately lead to premarket approval (PMA) here in the U.S."

FSS believes that this next generation femoropopliteal stent and delivery system can significantly 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. "The primary goal of a stent is to atraumatically keep a vessel open," stated Janet Burpee, FSS's CEO and co-inventor of the FlexStent technology. "The high radial strength, and equally important, the unique 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."

The company previously announced that it has received FDA 510(k) clearance for the biliary FlexStent^® system, and CE Mark authorization for the Biliary and Femoropopliteal FlexStent^® systems which includes the same enhanced stent delivery system to be used in the US clinical study.

Source: Flexible Stenting Solutions Inc