On-X® Life Technologies, Inc. (On-X LTI), today announced the publication of results of a large, prospective multi-center Canadian trial with the On-X® Prosthetic Heart Valve in the November issue of The Journal of Thoracic and Cardiovascular Surgery. According to the results of the report, “The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism, hemorrhage and composites of valve-related complications.”
“The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism, hemorrhage and composites of valve-related complications.”
The study was conducted with patients implanted with On-X valves between 2003 and 2008. Patients were monitored for thromboembolic (neuro) and hemorrhagic (bleeding) complications (events). The combined event rates for both aortic and mitral valve patients were below those observed in similar studies of both mechanical and tissue valves.
In a statement concerning this study, Clyde Baker, president and CEO of On-X Life Technologies, Inc., noted, “Remarkably, these results reflect the difference between the composite morbid event rates with the On-X valve when compared to competitors documented rates of complications. In this study, On-X valve patients had up to 66 percent fewer complications compared with competitive valves. That is stunning!”
According to Thierry G. Mesana, M.D., Ph.D., Deputy Director General at the Ottawa Heart Institute, in Ottawa, Ontario, Canada, “We have extensive experience with the On-X valve. It is very gratifying to see these results and know the benefits patients are realizing based upon the use of the On-X valve.”
W.R. Eric Jamieson, M.D., of the University of British Columbia in Vancouver, British Columbia, Canada, added, “The On-X valve is presently being studied in several trials that are testing the performance compared to competitive bileaflet valves. An additional study, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), will determine if patients may be maintained at significantly lower anticoagulation levels. The data from PROACT provide optimism that the other comparative trials will have successful results.”
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.
The On-X 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 valve can be safely maintained with reduced levels of warfarin anticoagulation or eliminate the use of warfarin altogether. The study is U.S. FDA approved and is being conducted in 40 centers in the U.S.
Source : On-X Life Technologies, Inc.