FSS Introduces Ground Breaking Stent Delivery Technology with the CE Marking of its Reconstrainable FlexStent® Femoropopliteal SE Stent System

EATONTOWN, N.J.--(BUSINESS WIRE)--Flexible Stenting Solutions, Inc. (“FSS”) is pleased to announce that it is now authorized to CE Mark and market its 6 Fr Reconstrainable FlexStent^® Self-Expanding Stent System in the European Union. FSS is a leading developer of next-generation peripheral, neurovascular and biliary stents. This new device combines the advanced FlexStent^® technology with unique reconstrainable stent delivery technology.

“FSS is always patient focused; we are very excited about this advanced safety feature.”

Reconstrainability enables the physician to fully recapture then reposition a partially deployed stent. Based on ongoing market research and physician feedback, FSS believes reconstrainability will be a powerful tool for optimizing stent placement in challenging vascular anatomies thereby enhancing overall patient safety. The Reconstrainable FlexStent^® Femoropopliteal Self Expanding Stent System is indicated for the treatment of symptomatic atherosclerotic disease of the femoropopliteal arteries. Stent and system sizes include stent diameters of 5, 6, 7, and 8 mm in lengths of 30 to 200 mm with delivery system lengths of 80 cm and 120 cm, as originally CE Mark authorized with the standard delivery system.

FSS intends to apply this novel reconstrainable delivery technology across its platform of current and future stent products. With the elegant and user-friendly reconstrainable delivery system, the complete FlexStent^® family of stents can be delivered with the same simplicity and low force demonstrated by the standard delivery system. Recapture and secondary deployment of the stent in the reconstrainable system are both accomplished with equal ease and simplicity.

Janet Burpee, FSS’s CEO, commented, “Our engineers and Chief Operating Officer, Bradley Beach, have exceeded my expectations in creating this novel delivery system.” She further stated that “FSS is always patient focused; we are very excited about this advanced safety feature.”

About Flexible Stenting Solutions Inc.

Flexible Stenting Solutions Inc. (FSS) is a leading developer of third-generation flexible peripheral arterial, venous, neurovascular and biliary stents, and reconstrainable delivery systems. Its nearly fully connected stent has coupled technology with clinical needs by providing an atraumatic, highly durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability. FSS is an ISO 13485:2003 certified company.

For further information on Flexible Stenting Solutions, please visit the company website at www.flexiblestent.com.

FlexStent^® is a registered trademark of Flexible Stenting Solutions, Inc.