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Edwards Lifesciences Sapien XT trial in Japan

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences' Sapien XT valve is being studied in Japan's first transcatheter aortic heart valve clinical trial, the firm announces April 26. Three leading Japanese cardiovascular centers are participating in the PREVAIL JAPAN trial, which will evaluate Sapien XT in Japanese patients suffering from severe aortic stenosis. Edwards says a successful trial could lead to Japanese approval by as early as 2013. The NovaFlex transfemoral and Ascendra 2 transapical delivery systems will both be studied in the trial. Sapien XT launched on a controlled basis in Europe in March and a full ramp-up is planned for the second quarter (1"The Gray Sheet" April 26, 2010)
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