Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for its Evoque tricuspid valve replacement system, which becomes the first transcatheter therapy to be approved in the United States for the treatment of tricuspid regurgitation.
The Evoque system is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy for whom tricuspid valve replacement is deemed appropriate by a heart team, the announcement said.
The availability of a transcatheter therapy for tricuspid valve replacement offers an option for older patients with severe tricuspid regurgitation who may be viewed as too high risk to undergo surgery.
The Evoque system, which has previously been given breakthrough status by the FDA, 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 transfemoral 28F system.
"Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options," said Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, NY.
Kodali was the lead investigator of the TRISCEND II study, which showed superiority of the Evoque system compared with optimal medical therapy alone. Key findings in the trial at 6 months, presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, included significant reduction or elimination of tricuspid regurgitation as well as significant and sustained quality of life improvement while demonstrating a favorable balance between risk and benefit, noted Edwards Lifesciences.
In addition to the 6-month cohort, 318 of the total 392 randomly assigned patients completed a 1-year follow-up, with results showing favorable trends in the device group compared with the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, and quality of life.
Edwards Lifesciences expects to present the full cohort of 392 TRISCEND II pivotal trial patients at the TCT meeting later in 2024.
The Evoque system received CE Mark approval in Europe in October 2023.