Results from a study comparing the On-X mechanical heart valve to tissue valves
Matched Patient Groups in Reduced Anticoagulation Trial Provide Evidence of Improved Mortality Rate for Patients
AUSTIN, TX – May 23, 2012 – On-X® Life Technologies, Inc. (On-X LTI) announced today that results from a study comparing the On-X mechanical heart valve to tissue valves conducted by Cardiac Surgical Associates of Florida were published in the May issue of the Annals of Thoracic Surgery. These results conclude that “Patients aged 65 or younger with (On-X) mechanical valves and closely monitored anticoagulation display non-inferiority to those with bioprostheses from bleeding and thromboembolic complications. Mechanical valves begin to confer mortality benefit over bioprostheses as early as 7.5 years postoperatively.”
Vinay Badhwar, M.D., principal investigator for the Reduced Anticoagulation for On-X Heart Valves: An Observational Non-Randomized Safety Study (REFORM), made the following comment concerning the importance of the study results, “This study confirms that the use of the On-X valve with home INR monitoring can provide a combined better outcome (adverse events and mortality) than that achieved by tissue valves with this younger (under 65 yrs) patient group.” Dr. Badhwar further notes that “the magnitude of the mortality benefit was an unexpected outcome – we found that in only 7.5 years the mortality differences would become statistically significant – this was surprising.”
The study was conducted with 172 patients with a mean age of 56.2 years, follow-up was 97% complete, with mean follow-up of 3.88 years. The study was multi-institutional and multi-surgeon and patients were matched by propensity scores for age, sex, valve position, New York Heart Association classification, ejection fraction, atrial fibrillation and serum creatinine all steps taken to mitigate bias.
“An early mortality benefit is important because it reflects positively on the On-X mechanical heart valve performance in the period before one would expect structural valve deterioration to begin negatively to affect tissue valve performance,” said John Ely, M.S., executive vice president of On-X LTI.
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 resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X heart 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.
On the basis of these results and others, the On-X heart valve is presently the subject of the ground-breaking PROACT study in the United States. The purpose of the PROACT trial is to determine if patients implanted with the On-X heart valve can be safely maintained with reduced levels of warfarin anticoagulation or eliminate the use of warfarin altogether. The study is U.S. FDA IDE approved and is being conducted in 40 centers in the U.S and Canada.
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® heart 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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Media Contact: Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, firstname.lastname@example.org.