SAN FRANCISCO, April 30, 2012 (GLOBE NEWSWIRE) -- On-X® Life Technologies, Inc. (On-X LTI) announced today that it is releasing the expected timelines for the initial submission to the FDA of modified "Instructions for Use" (IFU) of the On-X® Prosthetic Heart Valve based on data from the PROACT Anticoagulation Trial. The expected timelines are being provided to attendees of the 92nd Annual Meeting of the American Association for Thoracic Surgery (AATS) in the On-X Life Technologies exhibition booth number 517.
The first On-X Heart Valve IFU submission is based on the results of the High-Risk Aortic Valve Replacement Patient Group. It is anticipated that the submission will be made in the fall of 2012. The interim results report for the Low-Risk Aortic Valve Replacement Patient Group submission will follow in late 2012. The low-risk patients are being maintained with aspirin and clopidogrel only; no warfarin.
"The results of the PROACT trial appear thus far to be very positive," said Clyde Baker, On-X LTI's president. "The submission to the FDA of the IFU changes and the interim report for the aspirin and clopidogrel patient group will provide significant benefit to patients looking for a life-long correction of their valve problems, without the fear of reoperation in the next 10-15 years. Further, these clinical results are expected to have a very positive effect on the market penetration of the On-X valve and the growth of the company."
To obtain a copy of the expected timelines, contact On-X Life Technologies at onx@onxlti.com or (888) 339-8000.
More on the PROACT Trial
The preliminary report of PROACT (Prospective Randomized On-X Valve Anticoagulation Clinical Trial) data presented at the American College of Cardiology meeting in 2011 for the high-risk aortic patient test will provide the basis for modification of the IFU for the On-X Prosthetic Heart Valve. The modifications are expected to recommend that aortic valve replacement patients may be safely maintained at anticoagulation levels previously considered below professional society guidelines.
As had been hypothesized at the outset of the trial, patients in the test group with INRs between 1.5 and 2.0 are currently equal in composite thromboembolism and hemorrhage rates compared to the control group of patients. All patients received an On-X valve as a replacement for their aortic valve. High-risk aortic patients are those who have a higher potential for thrombotic or bleeding events. These were randomized into Test and Control groups for the trial. Both patient groups were maintained with standard anticoagulation therapy for the first three months after surgery and then randomized into their groups. The Test group was maintained with a daily dose of 81 milligrams of baby aspirin plus warfarin to achieve an INR target of 1.5 to 2.0. The Control group continued with standard anticoagulation therapy throughout the trial.
Present Guidelines (AHA/ACC) recommend patients with mechanical aortic valves be maintained at 2.0 to 2.5 INR. It is anticipated that with the lower levels of anticoagulation used during the PROACT trial that patients will experience fewer bleeding complications.
More about the On-X Prosthetic Heart Valve
The On-X 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 resulted 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® Life Technologies, Inc. (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.
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