Kensey Nash gets FDA clearance for its TriActiv embolic protection system

The TriActiv System, according to Kensey Nash, is an embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts. It aims to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack.

The tool contains an embolic protection balloon and a combined active flush and extraction system to remove the problematic debris from the treated vessel.

“Physicians will benefit from the use of this device in their practices,” said Joseph Carrozza, MD of Beth Israel Hospital, Boston, Massachusetts. “This new system has important advantages for physicians and patients, and should help advance clinical practice towards more universal usage of embolic protection for all SVG patients.”

Ultimately, the goal of the new product is to address blocked saphenous vein grafts, which according to Kensey Nash occurs within 10 years of cardiac bypass surgery. Current sales for embolic protection systems used during SVG procedures are estimated to approximate $100m worldwide and are expected to grow substantially over the next several years as next-generation products are developed and as indications are expanded.

The TriActiv System is currently approved for sale for the saphenous vein graft indication in the European Union. Kensey Nash is selling direct to customers in Germany and through distributors in other countries.