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Edwards Lifesciences Corp Receives Approval for SAPIEN XT in Japan


Monday, 24 Jun 2013 09:15am EDT 

Edwards Lifesciences Corp announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the commercially available transcatheter aortic heart valve. The Company expects to obtain reimbursement approval from MHLW by year's end, and will initiate a full launch in Japan immediately thereafter. In patients who are not good candidates for surgical aortic valve replacement, the Edwards SAPIEN XT valve can be implanted via a catheter into a beating heart. The device can be delivered through the transfemoral artery in the leg or transapically, through a small incision between the ribs. The valve's bovine pericardial tissue leaflets are based on Edwards' surgical heart valves. The Edwards SAPIEN XT valve has been studied in the treatment of thousands of patients in both commercial and clinical trial environments. The clinical study in Japan was conducted in cardiovascular centers Osaka University Hospital (Osaka), Sakakibara Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama). Additionally, the valve has been used widely by clinicians throughout Europe since its commercial launch in 2010. In the United States, the SAPIEN XT valve is not commercially available; it is an investigational device being studied as part of a randomized, pivotal clinical trial.