FDA Approves EVOQUE Tricuspid Valve Replacement System for Tricuspid Regurgitation

The US Food and Drug Administration has approved the EVOQUE tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR), according to a release from Edwards Lifesciences Corporation.

Announced on February 2, 2024, the system is indicated for improvement of health status in patients with symptomatic severe TR despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate, and represents the first transcatheter therapy to receive such an indication from the FDA.

“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” said Susheel Kodali, MD, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and principal investigator of the pivotal TRISCEND II Study.¹ “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients.”

The approval comes nearly half a decade after the FDA granted the EVOQUE system a Breakthrough Designation in 2019 and less than 6 months after the system received a CE mark from the European Medicines Agency. According to Edwards Lifesciences, the approval is based on data from the TRISCEND II trial, which was a randomized controlled trial aimed at assessing the safety and effectiveness of the system alongside optimal medical therapy compared against optimal medical therapy alone.¹

The full trial cohort encompasses 400 patients, with these patients randomized in a 2:1 ratio to the EVOQUE system or optimal medical therapy alone. As part of the trial, a prespecified analysis of the first 150 patients enrolled was included to evaluate the safety and effectiveness of the system.¹

At a late-breaking clinical trial session at the 35th Transcatheter Cardiovascular Therapeutics (TCT 2023), the community was offered insight into outcomes from those first 150 patients of the trial. Data from the presentation suggested the EVOQUE valve system was successfully implanted in 95.8% of patients and the trial met all primary endpoints, with 98.8% of patients achieving moderate or better TR and 93.8% achieving mild or better TR at 6 months.²

Additional highlights from the presentation included a major adverse event rate of 27.4% at 30 days and substantially superior quality-of-life and functional outcomes at 6 months for the composite endpoint including KCCQ, NYHA, and 6MWD.²

“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,” Kodali added.¹

In their release announcing the approval, Edwards Lifesciences also pointed out 318 of the 392 patients who had undergone randomization completed a 1-year visit. Among these patients, favorable trends were observed for those in the EVOQUE group for the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA and 6-minute walking distance. The release highlighted plans to present full cohort data at TCT 2024.¹

References:

1. Edwards Lifesciences. Edwards’ evoque valve replacement system first transcatheter therapy to earn FDA approval for tricuspid valve. Edwards Lifesciences. February 2, 2024. Accessed February 2, 2024. https://www.edwards.com/newsroom/news/2024-02-02-edwards--evoque-valve-replacement-system-first-tra.
2. Edwards Lifesciences. Triscend II six-month data for first 150 patients successfully demonstrate safety and efficacy of Edwards Evoque system for severe tricuspid regurgitation. Edwards Lifesciences. October 26, 2023. Accessed February 2, 2024. https://www.edwards.com/newsroom/news/2023-10-26-triscend-ii-six-month-data-for-first-150-patients-.