Edwards Lifesciences announced on 6 November 2009 the first successful Japanese implants of a transcatheter aortic heart valve using its Edwards Sapien valve.
The transfemoral and transapical valve implantations were performed by Osaka University in October in preparation for Osaka’s Senshin-Iryo application submission to the Japanese Ministry of Health, Labour and Welfare.
The Edwards Sapien valve was approved for sale in Europe in late 2007. It has been used in the treatment of thousands of high-risk patients in both commercial and clinical trial environments, and evaluated as part of nine rigorous scientific studies now complete or underway. In the United States, it is being studied as part of the world’s only randomised, pivotal clinical trial of a transcatheter aortic valve.