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.
