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# FDA Approves Medtronic CoreValve Evolut Valve
- URL: https://www.fdaweb.com/fda-approves-medtronic-corevalve-evolut-valve/
- Published: 2016-10-26T12:00:00.000Z
- Updated: 2026-09-14T21:42:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137184

FDA has approved Medtronic’s CoreValve Evolut R 34 mm valve, said to be the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The device is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm, according to the company. This large valve segment is estimated to account for about 25% to 30% of the eligible global TAVR patient population. It is delivered through the EnVeo R Delivery Catheter System, which features an inline sheath.