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Medtronic, Inc. (MDT) Clinical Trial Receives FDA Approval To Evaluate New CoreValve(R) System For Aortic Valve Implantation



10/18/2010 9:51:25 AM

Medical News Today -- Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI). The CoreValve System is designed to provide a minimally invasive, non-surgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery. Worldwide, approximately 300,000 people have been diagnosed with this condition, and approximately one-third of these patients are deemed at too high a risk for open-heart surgery,1 the only therapy with significant clinical effect that is currently available in the United States. The Medtronic CoreValve System will soon be under investigational use and is not yet commercially available in the U.S.



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