Kensey Nash Announces CE Mark Approval for triActiv FX System

Kensey Nash has received CE Mark approval for a new triActiv FX System, allowing sale of the product throughout the European Union.

The triActiv FX System incorporates several important ease-of-use design enhancements to the triActiv System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a monorail flush catheter to enhance device usage and reduce procedure time. A multicenter, nonrandomized clinical study, to support regulatory clearance of the triActiv FX System in the U.S., will begin later this month.

The triActiv FX System is designed to prevent heart attacks during the interventional treatment of saphenous vein grafts in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The company is preparing to launch the product through its direct sales force and distributors throughout Europe.