The U.S. Food and Drug Administration (FDA) has approved the EVOQUE tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR). According to an Edwards press release, “it is the first transcatheter therapy to receive [FDA] approval for the treatment of [TR]” and is “indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.”

The agency granted approval based on six-month results from the TRISCEND II trial, which were presented during TCT 2023 and provided an early look at the safety and effectiveness based on the first 150 patients enrolled in the trial. Early findings showed transcatheter tricuspid valve replacement with the EVOQUE system effectively eliminated TR in a vast majority of patients despite more than 55% having massive or torrential TR and the remainder being categorized as severe.

According to Edwards, “in addition to the six-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, KCCQ, NYHA and 6MWD.”

The design of TRISCEND II is based on FDA breakthrough designation. Results from the full cohort are expected to be presented at TCT 2024.