Flexible Stenting Solutions (FSS) has received CE Mark for 6 Fr Reconstrainable FlexStent self-expanding stent system and will now be able to market the stent delivery technology in the European Union.
The new device, which integrates the FlexStent technology with reconstrainable stent delivery technology, is used in the treatment of symptomatic atherosclerotic disease of the femoropopliteal arteries.
FSS CEO Janet Burpee said, "Our engineers and Chief Operating Officer, Bradley Beach, have exceeded my expectations in creating this novel delivery system."
The company will make the stent and system available in varying sizes with stent diameters of 5mm, 6mm, 7mm and 8mm in 30mm to 200mm lengths with delivery system lengths of 80cm and 120cm.
Reconstrainability will allow physicians to recapture and reposition a partially deployed stent.