- 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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UPDATE: Medtronic plc: FDA Approves the VenaSeal Closure System for Treatment of Clinically Symptomatic Venous Refluxat Benzinga.com (Tue, 1:02PM)
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