Medtronic CoreValve® system obtains early FDA approval on exceptional clinical pe
Medtronic, Inc. has announced the U.S. Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve® System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50 percent at one year. The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S.
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Medtronic, Inc. has announced the U.S. Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve® System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50 percent at one year. The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S.
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