PROACT
(Prospective Randomized On-X Valve Anticoagulation Clinical Trial)
Clinical trials have shown that the On-X valve surpasses all other valves on the market in hemodynamic performance. The valve received full pre-market approval from the FDA in March of 2002.
In January of 2006, the FDA approved the first and only IDE (Investigational Device Exemption) lowered anticoagulation trial (PROACT Study--reduced INR) for a mechanical valve to be conducted at 40 sites in the United States for the On-X Prosthetic Heart Valve.
Please click on the white arrow in the middle of the video screen to view the video. Thank you.