FSS gets CE mark for self-expanding stent
New Jersey's Flexible Stenting Solutions snagged a CE mark for another entry in its FlexStent family, a self-expanding device designed to treat atherosclerotic disease in the iliac arteries.
FSS plans to launch the device in Europe in the third quarter of this year, making it the third self-expanding tech the company has on the market there. Already approved are models designed for the femoropopliteal and biliary arteries, and the latter got 510(k) clearance in the U.S. in 2010.
The nitinol-based stents treat peripheral artery disease, and their helically wound struts with helical coils make them flexible, minimizing the risk of breakage, vessel damage and restenosis in the lower extremities, according to the company. FSS says its self-expanding tech provides greater ease of placement for physicians than other stents on the market, and the company is looking to expand to treat other arteries in the future. "FSS's continued goal is to work towards expansion of the indications of this unique stent and simplify the peripheral vascular stenting procedure so the physician can focus on the patient," CEO Janet Burpee said in a statement.
Of course, FSS is hardly alone in the PAD-treating-stent market. Cook Medical is expanding its Zilver line of stents around the world, and Boston Scientific ($BSX), after getting a CE mark, is seeking FDA clearance for Epic, its own self-expanding tech.
- read FSS's release