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FDA Approves Kensey Nash's TriActiv System

March 25, 2005

Medical devicemaker Kensey Nash has received clearance from the FDA to sell its TriActiv System in the U.S., and will launch the product through its new direct sales force.

The TriActiv System prevents material or debris, dislodged during stent procedures, from traveling downstream and causing adverse coronary events such as a heart attack. The system includes an embolic protection balloon, and a combined active flush and extraction system to remove the debris from the treated vessel.

The FDA clearance was based on an 894-patient clinical safety and efficacy study. TriActiv is currently approved for sale in the European Union.