> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Medtronic’s CoreValve Evolut Valve
- URL: https://www.fdaweb.com/fda-approves-medtronics-corevalve-evolut-valve/
- Published: 2017-03-22T12:00:00.000Z
- Updated: 2026-09-14T22:13:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138272

FDA has approved a Medtronic PMA for the CoreValve Evolut PRO valve for treating severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval was based on 30-day clinical data that “showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve,” according to the company. The device is designed with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance, Medtronic says, adding that the “biocompatible porcine pericardial tissue wrap... is incorporated to address the occurrence of blood leaking through the sides of the valve.” The valve is delivered through the company’s EnVeo R Delivery Catheter System and is indicated for vessels down to 5.5 mm.