Edwards Evoque Tricuspid Valve Replacement System Approved by FDA

February 2, 2024—Edwards Lifesciences Corporation announced FDA approval of the company’s Evoque transcatheter tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR).

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

In October 2023, Edwards announced that the Evoque system received European CE Mark approval.

The company noted that 6-month results from the TRISCEND II randomized controlled pivotal trial were presented during a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23 to 26 in San Francisco, California.

At 6 months, the study met all primary endpoints, demonstrating favorable safety and effectiveness outcomes and superiority to OMT alone. Key findings included significant reduction or elimination of TR, significant and sustained quality-of-life improvement, and a favorable balance between risk and benefit.

In addition to the 6-month cohort, 318 of the total 392 randomized patients completed a 1-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, heart failure hospitalization, Kansas City Cardiomyopathy Questionnaire score, New York Heart Association class, and 6-minute walk distance.

Edwards expects to present the full cohort of 392 patients in the TRISCEND II at TCT 2024, which will be held October 27 to 30 in Washington, DC.

Susheel Kodali, MD, Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital in New York, New York, is Principal Investigator of TRISCEND II.

“Patients suffering with TR endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” commented Dr. Kodali in the company’s press release. “The Evoque system is able to replace the native tricuspid valve, virtually eliminating TR in a wide range of patients.”

Dr. Kodali continued, “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.”