Enrollment Objective Achieved for Aspirin and Clopidogrel Patient Group of the On-X Life Technologies, Inc. Heart Valve Anticoagulation Clinical Study
Published: Jul 26, 2011
The Low-Risk Patient Group of the PROACT clinical trial is comprised of patients requiring aortic valve replacement who meet the low-risk criteria established by the study’s protocol, which was reviewed and approved by the FDA. This is the only FDA-approved study using aspirin and clopidogrel as the anticoagulant for aortic valve patients receiving a mechanical valve. The unique and innovative design and material features of the On-X valve combined with the previously-established clinical data for the valve made approval of this study by the FDA reasonable.
“The completion of the enrollment objective for the low-risk aspirin and clopidogrel patient group is a very positive sign,” said John Puskas, M.D., M.Sc. Chief of Cardiac Surgery, Emory University Hospital Midtown, and Associate Chief of Cardiothoracic Surgery, Emory University Hospital, and International Principle Investigator for the PROACT trial. “Thus far, we have seen a very low incidence of complications with this group. When the longer-term follow-up data are collected, analyzed and reviewed, we will be able to determine whether recipients of the On-X valve in the aortic position can be safely managed without warfarin anticoagulation. If that is the case, it will be an important breakthrough for prosthetic valve recipients.”
A preliminary report of PROACT trial data for the high risk aortic patient group was previously presented by Dr. Puskas to the American College of Cardiology in April 2011. Those data showed that 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.
“The completion of enrollment for the low risk aortic patient group is personally very exciting,” said Allen Henry Graeve, M.D., site Investigator at Tacoma General Hospital, Tacoma, Washington. “We just crossed a milestone with one of our On-X Aortic Heart Valve patients, who has been successfully maintained for more than five years on aspirin and Plavix – and no Coumadin®. We look forward to offering the opportunity for an improved and active quality of life to many more patients in the future.”
“The real ‘game-changer’ for our patients and for our company would be obtaining the FDA’s approval to change our Instructions for Use for the On-X Valve to include the opportunity to permit reduction in patient anticoagulation, typically Coumadin, which is unavailable with any other mechanical valve,” said Clyde Baker, On-X LTI’s president. “The achievement of this enrollment objective for this most important aspirin and Plavix group is a major milestone needed to achieve that objective. We anticipate completing enrollment of the mitral valve patient group later this year and expect to submit and report additional results for all patient groups publicly during 2012.”
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.
Until the completion and analysis of study data, On-X Life Technologies, Inc., continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.
About On-X LTI
On-X® Life Technologies (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.
On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.
Plavix is a registered trademark of Sanofi-Aventis.
Coumadin is a registered trademark of Bristol-Myers Squibb.
Media Contact: Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, firstname.lastname@example.org