Clinical Trial Shows Results for Prosthetic Heart Valve

(Yale School of Medicine/Wikimedia Commons)

On-X Life Technologies Inc. in Austin, Texas, said today results of a large, multi-site clinical trial of its On-X prosthetic heart valve showed favorable outcomes for patients with the device on freedom of thromboembolism (blood clotting) and hemorrhaging. The findings were published in the November issue of the Journal of Thoracic and Cardiovascular Surgery (paid subscription required).

The study was conducted in Canada with 737 patients implanted with On-X valves between 2003 and 2008. The patients were monitored for thromboembolic and bleeding complications. Combined rates of complications for both aortic and mitral valve patients were below those observed in similar studies of both mechanical and tissue valves.

The company says its On-X valve is made of pure pyrolytic carbon, which provides a surface more resistant to blood clotting. The carbon’s strength also makes it possible to include design changes that lets the prosthetic valve act more like a natural valve in its treatment of blood.

On-X says the valve is being tested in another clinical trial in the U.S. This trial will help determine if patients implanted with the On-X valve can be safely maintained with reduced levels of warfarin anticoagulation or eliminate the use of warfarin altogether.

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