Edwards Lifesciences Receives IDE for US Clinical Trial of Sapien 3

Edwards LifesciencesCorporation (NYSE: EW), the global leader in the science of heartvalves and hemodynamic monitoring, today announced that it hasreceived conditional Investigational Device Exemption (IDE) approvalfrom the U.S. Food and Drug Administration (FDA) to initiate aclinical trial of its Edwards SAPIEN 3 transcatheter aortic heartvalve and accessories. The trial will study the SAPIEN 3 valve in the treatment of high-riskand inoperable patients with severe symptomatic aortic stenosis. Itwill enroll up to 500 patients treated with one of three deliverytechniques: the transfemoral approach through an incision in the leg,the transapical route between the ribs or the transaortic approachthrough a small incision in the chest and aorta. Edwards anticipatesthat the trial will have a one-year composite endpoint compared toprevious SAPIEN valves.