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.

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Comments (1)
  • hermanbrut
    , contributor
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    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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