FSS initiates FlexStent clinical trial for treatment of peripheral arterial disease

Flexible Stenting Solutions Inc. announced today the successful treatment of the first two patients enrolled in the OPEN (Evaluation of Safety and Efficacy of the FlexStent^® FemorOPopliteal Self-Expanding StENt System) clinical trial. The first patient was treated at Midwest Cardiovascular Research Foundation located in Davenport, Iowa by the site's Principal Investigator and President, Dr. Eric J. Dippel. Shortly thereafter, FSS's National Study Principle Investigator for the OPEN trial, Dr. William Gray, treated his first patient at Columbia-Presbyterian Hospital where he is the Director of Endovascular Intervention.

The intent of the OPEN clinical trial is to demonstrate that the FlexStent^® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent^® shall meet or exceed the proposed safety and efficacy performance goals established for femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease (PAD). The OPEN trial is a prospective, single-arm trial enrolling up to 227 patients at as many as 40 clinical sites.

After enrolling the first study patient, Dr. Dippel commented, "The delivery is straightforward, quick and accurate. The acute result was excellent." Dr. Gray added, "We are excited to see this trial initiated and congratulate Dr. Dippel and his team on a successful implant. The unique design of the FlexStent^® and prior experience outside the United States are anticipated to result in excellent outcomes for patients treated in the OPEN trial."

FSS has focused on physician requests for a flexible, durable, conformable and easy-to-deliver stent. The FlexStent^® Self-Expanding Stent System has already received CE Mark authorization for peripheral vascular use and US 510(k) clearance for palliative treatment of biliary strictures produced by malignant neoplasms. "We feel the FlexStent^® for the treatment of PAD in the femoropopliteal arteries will be an important addition to patient care in the U.S.," stated Janet Burpee, FSS's CEO. "We are lucky to have Dr. Gray as the National PI and are pleased that Drs. Dippel and Gray have successfully kicked off the OPEN trial. With many other great physicians participating, we expect speedy enrollment and an overall successful clinical trial."