FDA Clears Medtronic CoreValve Transcatheter Aortic Valve

Self-expanding valve is the second transcatheter aortic valve on U.S. market
By: 
Dave Fornell

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January 17, 2014

Medtronic’s self-expanding transcatheter aortic valve replacement (TAVR) CoreValve System is the first self-expanding TAVR valve to be approved in the United States and the second TAVR valve to achieve FDA approval (Jan. 17, 2014).  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. Pivotal Trial, 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 new valve is indicated 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 CoreValve System was developed to serve the needs of the broadest range of patients with severe aortic stenosis. The FDA approved the entire CoreValve platform including the CoreValve Evolut 23 mm, and the CoreValve 26, 29 and 31 mm valves. With the broadest size range available, the CoreValve System is suitable for patients with native valves of nearly all sizes. Its self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement. All valve sizes are delivered via the smallest (18 French, or 6 mm) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature. Since obtaining CE (Conformité Européenne) mark in 2007, the CoreValve System has been implanted in more than 50,000 patients outside the United States. For more information: www.corevalve.com  

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