FSS receives the CE mark for its new reconstrainable FlexStent femoropopliteal self-expanding stent system


Flexible Stenting Solutions (FFS) announced on 21 December 2012 that it has received the CE mark and is now authorised to market its 6F reconstrainable FlexStent self-expanding stent system in the European Union. FSS is a developer of next-generation peripheral, neurovascular and biliary stents. This new device combines the advanced FlexStent technology with unique reconstrainable stent delivery technology, the company said.

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 optimising 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 8mm in lengths of 30 to 200mm with delivery system lengths of 80cm and 120cm, as originally CE mark authorised 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,” informed a press release issued by the company.

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.”