The U.S. Food and Drug Administration (FDA) has approved 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, according to an announcement by Medtronic, Inc.

The FDA based its approval on the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal trial presented at TCT 2013, which demonstrated that the CoreValve System is "safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported." The FDA granted approval of the device without an independent device advisory panel review. As a result of collaborations between your ACC, the Society of Thoracic Surgeons and the Centers for Medicare and Medicaid Services, there will be a seamless transition for the device from an unapproved, experimental technology to a Medicare covered service.

Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Centers for Medicare and Medicaid Services, U.S., Heart Valve Prosthesis, Stroke, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration

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