AUSTIN, TX (October 20, 2009) – Austin-based On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve and On-X® carbon products for orthopedic implants, announced today that enrollment in the High-Risk Patient Group of the landmark PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) is complete. While data is still to be analyzed, it is a positive indication that the trial has reached full enrollment of the High-Risk Aortic Valve Replacement Patient Group without an adverse incident that would lead the study’s Data Safety Committee to conclude the study prematurely.
Based upon existing clinical data, The U.S. Food and Drug Administration approved the PROACT trial in January 2006. The study is being conducted in 40 world-class clinical sites in the U.S.
The patient groups in the study include low-risk aortic valve replacement patients, higher risk aortic valve replacement patients and mitral valve replacement patients. Higher risk patients include those with heart rhythm problems, left ventricular dysfunction, previous thrombo-embolism and condition of hypercoagulability. It is within the higher-risk aortic patient group where enrollment is complete.
“This is the first FDA trial to explore lower anticoagulation with a mechanical heart valve,” said Professor John D. Puskas, M.D., associate chief, Division of Cardiothoracic Surgery at Emory University School of Medicine in Atlanta, Georgia, the study’s Principle Investigator.
“Although we must wait until the clinical data are analyzed, the completion of enrollment of the high-risk aortic patient group without a significant number of patient events provides optimism toward an eventual good result,” said Dr. Puskas. “The exciting thing about this trial is the opportunity it may provide patients to choose a durable mechanical valve for life with complications similar to those of less durable tissue valves – meaning they may not have to face either an increased risk of bleeding or valve failure,” notes Dr. Puskas.
“This is a significant achievement for On-X LTI and the On-X heart valve,” said Clyde Baker, president and CEO of On-X Life Technologies, Inc. “But more importantly, when the data are available and we have sufficient evidence of efficacy, we will apply to authorities to modify our product labeling significantly to permit modification of anticoagulation protocols with the On-X valve, a change that will provide an immediate clinical benefit to patients.”
“We are extremely appreciative to the patients involved in this study, to the leadership of Dr. Puskas and the many surgeons and coordinators within these 40 institutions for conducting the trial thus far, and we look forward to the data analysis and completion of enrollment in the other patient groups within the PROACT trial,” notes Baker.
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 thrombo-resistant surface, the comparatively high strength of pure On-X carbon enabled On-X LTI to make significant valve design changes that resulted in a prosthetic 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.
First implanted in 1996, recent clinical evidence suggests that patients implanted with the On-X heart valve may be able to reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.
The FDA approved the On-X aortic and mitral valves for commercial use in the United States on May 30, 2001, and March 6, 2002, respectively. More than 70,000 On-X valves have been implanted since 1996.
About On-X Life Technologies, Inc.
On-X LTI develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. The company also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. On-X LTI was founded in 1994 by a team of heart valve material and design scientists and engineers led by pioneer Jack Bokros, Ph.D. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas. More information is located at www.onxlti.com.
On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.
