Kensey Nash Updates TriActiv System Regulatory and Sales Status

Kensey Nash has said it is in the process of responding to requests from the FDA regarding its 510(k) application for the TriActiv System.

The TriActiv System is an embolic protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events, such as a heart attack.

The FDA's requests focused on labeling and clarification of previously submitted data. The 510(k) application submitted to the FDA contains data from the company's PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) trial which randomized the TriActiv System against other approved embolic protection systems or the standard of care, and measured major adverse cardiac event rates in the treatment of saphenous vein graft disease.