Medtronic Announces FDA Approval for New TAVR System, Introduces First and Only Recapturable Heart Valve in U.S.

Industry News

U.S. FDA has approved the CoreValve Evolut R System for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery.  The CoreValve Evolut R System is the first recapturable and repositionable device available in the US developed and manufactured by Medtronic, a global medical device company.  Aortic stenosis occurs when the heart’s aortic valve narrows, preventing the valve from opening fully.  Left untreated, aortic valve stenosis can lead to serious heart problems including heart failure.  TAVR is a procedure for high risk patients with severe aortic stenosis who are unable to undergo aortic valve surgery.  The CoreValve Evolut R System is built on the foundation of CoreValve System, which was approved by the FDA in March this year.  It is optimized to increase conformability and sealing at the annulus while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance.  These improvements will enable physicians to deliver better patient outcomes.


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