Highlighting 15 Years of Implant Excellence
At the EACTS meeting in Lisbon, Portugal
Two ten-year clinical research reports present evidence of continuing superior performance of the On-X® Prosthetic Heart Valve in diverse European and South African patient groups
AUSTIN, TX — July 26, 2011 — On-X® Life Technologies, Inc. (On-X LTI) announced today that it is highlighting two clinical studies completed during the first 15 years of the On-X Prosthetic Heart Valve implant experience at the European Association for Cardio-Thoracic Surgery meeting being held Lisbon, Portugal, on October 2-5, 2011. The reports consist of a a ten-year multiple center European study and a ten-year study of patients with poor anticoagulation control in South Africa. These studies in vastly diverse patient populations provide evidence of the continuing superior performance of the On-X Prosthetic Heart Valve.
The South African study provides a stunning example of the On-X valve to reduce complications despite adverse anticoagulation compliance. For example, with an approximately 50 percent noncompliant patient group in this study, the thrombosis rate remains 0.2 percent per patient-year comparing favorably to competitive valves with 2.0 percent per patient-year to 6.0 percent per patient-year thrombosis rates in this same patient population.1
“We are very pleased with the continuing record of clinical evidence demonstrating the benefit of the On-X valve’s unique design with many categories of patients in diverse geographic and clinical settings,” said Clyde Baker, On-X LTI’s president. “The results emphasize the ability of the On-X valve to tolerate an inconsistent INR level, to provide the lowest possible levels of clinical complications and to help heart valve replacement patients maintain an active life, without severe risk of reoperation at an advanced age.”
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.
- Williams MA, Crause L, Van Riet S. A comparison of mechanical valve performance in a poorly anticoagulated community. J Card Surg 2004;19:410-14
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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
