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Approval for the sapien xt transcatheter heart valve, model 9300tfx, and accessories. this device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. e., society of thoracic surgeons operative risk score >8% or at a >15% risk of mortality at 30 days).
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