On-X Heart Valve Study Results
Presented at the Society for Heart Valve Disease 7th Biennial Congress
Two PROACT Abstracts Present Data Showing Patients on Low Anticoagulation Therapy Do Well with the On-X® Prosthetic Heart Valve
AUSTIN, TX — June 25, 2013 — On-X® Life Technologies, Inc. (On-X LTI) announced today that two new PROACT abstracts further demonstrating the safety of maintaining On-X® Prosthetic Heart Valve patients on anticoagulation therapy below currently recommended guidelines are being presented at the Society for Heart Valve Disease 7th Biennial Congress in Venice, Italy, being held June 22-25, 2013.
“Serial Echocardiograms During 5-Year Folllow-up After Aortic Valve Replacement in the PROACT Trial” is being presented by Marc Gerdisch, M.D., Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Heart Center, Indianapolis, Ind. This study was conducted to determine any relationship between echo outcomes and adverse events. Data collected at one, three and five years postoperatively show no relationship between adverse events and On-X valve size or hemodynamic characteristics. Moreover, echo evaluation up to five years showed no change in hemodynamic performance of the valve, including patients managed with lower anticoagulation.
Dennis Nichols, M.D., Cardiac Surgeon and PROACT Principle Investigator at Tacoma General Hospital, Tacoma, Wash., will present “Prevalence of Risk Factors and Low Response to Antiplatelet Medications in the Prospective Randomized On-X Anticoagulation Clinical Trail (PROACT).” This study examined the occurrence of risk factors for thromboembolism and antiplatelet response in patients to screen them for participation in the Low Risk Treatment Group of patients—those taking aspirin and clopidogrel (Plavix®)—in the PROACT trial. The non-response rate of patients for the Low Risk Treatment Group for clopidogrel was 47.1% and for aspirin was 80.4%, enabling rapid enrollment in the High Risk Patient Treatment Group of the PROACT trial.
“The PROACT trial is innovative and unique for producing the never-before-seen data related to the On-X® valve implant,” said Clyde Baker, On-X LTI’s president. “Countless valve studies have reviewed simple clinical or hemodynamic results but have not examined these important data points.”
More about the On-X Valve and PROACT Trial
On-X heart valves are made of pure On-X Carbon® and have an advanced design that causes less blood cell damage than traditional mechanical valves. Long-term studies have documented fewer morbid events in recipients of On-X valves. Presently, the Prospective Randomized On-X Valve Reduced Anticoagulation Clinical Trial (PROACT) is examining if patients may require less anticoagulation.
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 (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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On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.
Media Contact: Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, cbaker@onxlti.com
