Edwards Lifesciences announced the company’s Evoque tricuspid valve replacement system received US Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation. 

Evoque is an artificial heart valve that can be implanted using a delivery catheter without open-heart surgery. The Evoque valve is intended to treat patients with severely leaky tricuspid valve—tricuspid regurgitation—often caused by an enlarged heart or damaged native valve flaps who continue to experience symptoms despite being on heart failure medications. 

The approval marks the first transcatheter replacement device indicated for use in the tricuspid position.

The Evoque system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the company’s proven bovine pericardial tissue. The Evoque valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.

Six-month results from the randomized controlled pivotal trial, TRISCEND II, presented last year at TCT 2023, reported favorable safety and effectiveness outcomes, demonstrating superiority to optimal medical therapy alone and meeting all primary endpoints. 

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.

In addition to the six-month cohort, 318 of the total 392 randomized patients completed a one-year visit. The results showed favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, and heart failure hospitalization. Edwards expects to present the full cohort of 392 TRISCEND II pivotal trial patients at TCT 2024.

“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” says Susheel Kodali, MD, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II study principal investigator, in a release. “The Evoque system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients. We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients.”

The Evoque system received CE Mark approval in October 2023.

Photo caption: Evoque System

Photo credit: Edwards Lifesciences