AUSTIN, TX – October 22, 2012 – On-X® Life Technologies, Inc. (On-X LTI) announced today that it has submitted applications for review and approval to the United States Food and Drug Administration (USFDA) and to the Conformité Européenne (CE) with new Instructions for Use (IFU) that recommend use of the On-X Aortic Valve at reduced levels of anticoagulation. The applications were submitted based upon the results of the high-risk aortic valve patient group of the Prospective Randomized On-X Valve Anticoagulation Trial (PROACT). If the IFU is approved, the On-X valve will become the first mechanical aortic heart valve that may be maintained at these lower INR levels.
The new IFU would permit the use of the On-X valve at anticoagulation levels previously considered below professional society guidelines set by the American Heart Association and American College of Cardiology and below that of all other mechanical aortic valves, providing patients with the opportunity to reduce complications normally associated with prosthetic heart valves.
“The major concern with use of anticoagulants such as warfarin is bleeding,” said Marc W. Gerdisch, M.D., director of Cardiothoracic Surgery at St. Francis Heart Center of Indianapolis and a clinical investigator for the PROACT trial. “The PROACT trial results show that On-X aortic heart valve recipients can be safely maintained at much lower INR levels than other mechanical heart valves, thereby significantly reducing the risk of bleeding complications.”
The level of anticoagulation activity is measured as international normalized ratio (INR). INR is used to determine the clotting tendency of blood. INR in the absence of anticoagulation therapy is normally 0.8-1.2. The target range for INR in anticoagulant use (e.g. warfarin) varies depending upon indication for therapy. Professional societies have recommended that patients with mechanical aortic heart valves in the absence of thromboembolic risk factors be maintained at 2.0-3.0 INR.
The modified IFU for the On-X aortic valve will recommend an INR range of 1.5-2.0 INR for all aortic valve patients. The reduction of INR in the PROACT trial has resulted in a statistically significant reduction of nearly 50% in bleeding events for the test patients.
“The PROACT results, the IFU modification (when approved), and the accompanying benefit of reduced bleeding events for patients receiving the On-X aortic valve are extremely meaningful for patients needing prosthetic valves,” said Clyde Baker, On-X Life Technologies CEO. “Younger aortic heart valve replacement patients — those 65 years and under — now have a much safer and permanent resolution to this common cardiac condition. They can now make a choice for low complications and not be faced with the trauma of a likely future cardiac reoperation.”
More about the On-X Prosthetic Heart Valve
The On-X heart valve is the result of a breakthrough in medical grade carbon technology—On-X® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X® carbon enabled On-X LTI to make significant valve design changes that results in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.
About On-X LTI
On-X® LTI develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X® valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.