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# Edwards Tricuspid Valve Replacement Approved
- URL: https://www.fdaweb.com/edwards-tricuspid-valve-replacement-approved/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:22:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156279

FDA has approved Edwards Lifesciences’ Evoque tricuspid valve replacement system for treating tricuspid regurgitation (TR). The device is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team, according to the company.

Evoque comprises a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from bovine pericardial tissue, Edwards says, adding that it is available in three sizes, all delivered through the same low-profile transfemoral 28F system.

The device’s approval is based on data from the pivotal TRISCEND II trial which met all primary endpoints, Edwards says. “Key findings in the trial included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit,” it says.