Edwards Announces FDA Approval of Triformis Resilia Surgical Tricuspid Valve

Edwards Lifesciences said it has received US Food and Drug Administration approval for Triformis Resilia, a surgical replacement valve that the company describes as the first designed specifically for patients with tricuspid valve disease, MedTech Dive reported on June 3.

The FDA's premarket approval database lists the valve under supplement S092 to PMA P150048, a panel-track supplement received on April 30, 2025, with a decision date of October 27, 2025. According to the approval order statement, the FDA approved Edwards' MITRIS RESILIA mitral valve "for expanding the indications to include the tricuspid position," with the modified device to be marketed as the TRIFORMIS RESILIA Tricuspid Valve. It is indicated for the replacement of native or prosthetic tricuspid heart valves.

Approval built on real-world data

The FDA's summary of safety and effectiveness data says the approval rested on a retrospective analysis of real-world, off-label use rather than a new prospective trial. The analysis drew on de-identified electronic health records and claims data from 19 US integrated delivery networks, which the summary says capture about 18% of care delivered in the US.

Reviewers identified 204 patients who underwent surgical tricuspid valve replacement between January 1, 2016, and August 30, 2024, using one of Edwards' mitral valves: 147 received a Magna Mitral Ease valve and 57 a MITRIS RESILIA valve. The summary describes the Magna models as earlier design iterations that share the MITRIS RESILIA valve's core technological characteristics. Nearly half of the patients (99 of 204, or 48.5%) were undergoing replacement for active infective endocarditis.

At one year, the estimated all-cause mortality rate was 26.5% and the cumulative incidence of heart failure hospitalization was 21.4%, according to the summary. Median follow-up was 303 days. The valve is available in sizes 25, 27, 29, 31 and 33 millimeters.

Design and context

The valve has a flattened sewing ring shaped to mirror the annulus of the native tricuspid valve and extends Edwards' Resilia tissue technology to the tricuspid position, a company spokesperson told MedTech Dive. The original PMA covered Edwards' aortic pericardial valves, approved in 2017, and a mitral model was added in 2018, according to the FDA summary.

Edwards said surgery for isolated tricuspid regurgitation is rarely performed because of concerns about high mortality risk. The company pointed to a recent analysis of a Society of Thoracic Surgeons database whose model predicted an operative mortality risk of 5.6%, and said the approval was timely given that benchmark, MedTech Dive reported.

Edwards also makes the Evoque transcatheter tricuspid valve replacement system, approved in 2024, and is awaiting an FDA decision on a label expansion for its Pascal transcatheter repair system in tricuspid disease, according to MedTech Dive. The company did not disclose why it announced the surgical valve approval several months after the FDA's decision date.