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FDA approves Medtronic heart valve system early

  • Medtronic (MDT +0.4%) says it received FDA approval, three months earlier than expected, to sell its CoreValve heart valve technology for patients too frail for traditional surgery approval.
  • The approval allows MDT to begin competing against Edwards Lifesciences (EW -5.1%), whose similar Sapien device has been approved for a wider range of patients, including those who are eligible for surgery, but who are considered at high risk for complications.
  • CoreValve is approved for patients with severe aortic stenosis who are too sick or frail to undergo open-heart surgery; in a clinical trial, patients receiving the device had a 25% rate of death or major stroke after one year vs. an estimated rate of 43% had the patients received medication therapy.
Comments (1)
  • hermanbrut
    , contributor
    Comments (261) | Send Message
     
    Since Edwards won a patent decision by jury against Medtronic on this device and was awarded over $300 million, and royalties for future sales, isn't this also good news for EW?
    17 Jan 2014, 02:28 PM Reply Like
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