> ## 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.

# Medtronic’s Evolut FX TAVR System Approved
- URL: https://www.fdaweb.com/medtronics-evolut-fx-tavr-system-approved/
- Published: 2021-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:11:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149994

FDA has approved a Medtronic PMA for its next-generation, self-expanding transcatheter aortic valve replacement (TAVR) system — the Evolut FX TAVR system. The device is designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the company says. It is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant procedures. “In addition, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment,” it says. Evolut FX is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).