Kensey files 510(k) for embolic protection:

Kensey Nash has moved closer to entering the US market for embolic protection devices, after submitting a 510(k) marketing application to the FDA for its TriActiv system. The product is designed to prevent debris, dislodged during stenting procedures, from embolising downstream and causing adverse coronary events. It incorporates an embolic protection balloon, and a combined active flush and extraction system to remove the debris from the vessel. The 510(k) application contains data from a trial comparing TriActiv against other approved embolic protection systems for the treatment of saphenous vein graft (SVG) disease. The current market for embolic protection systems is estimated to approximate $100m worldwide and is expected to grow substantially over the next several years as next generation products are developed and as indications are expanded, said the Exton, Pennsylvania firm. The TriActiv system is approved in Europe for the SVG indication.