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Edwards +3.7% AH; FDA approves Sapien XT valve

  • The FDA has approved Edwards' (EW) Sapien XT transcatheter aortic heart valve for "the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis."
  • The low-profile valve, available in Europe since 2010 and Japan since 2013, will now be available to U.S. patients "at leading cardiovascular centers across the nation." Edwards predicts it will increase the number of treatable patients.
  • Previous: Sapien XT beats Medtronic device in study
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