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The FDA approved the Evoque tricuspid valve replacement system as the first transcatheter treatment for tricuspid regurgitation (TR), Edwards Lifesciences .

Evoque gained an indication for severe TR that is symptomatic despite optimal medical therapy in patients for whom a multidisciplinary heart team deems the approach appropriate.

The prosthesis features a nitinol self-expanding frame, intra-annular sealing skirt, and bovine pericardial tissue leaflets as used in the company's transcatheter valves for aortic applications. The tricuspid valve comes in three sizes, all delivered through a transfemoral 28F system.

"The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients," said Susheel Kodali, MD, of Columbia University Irving Medical Center/New York-Presbyterian Hospital in New York City, in a .

He led the pivotal TRISCEND II trial upon which approval was based.

Results from the 6-month data on the first 150 patients out of the full 392-patient TRISCEND II trial were reported by 名媛直播 at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October.

They showed a major adverse event rate of 27.4%, less than the expected 43.8% (based on isolated tricuspid valve replacement surgery from Medicare claims) and what Kodali at the time had called an "acceptable safety profile in a highly comorbid patient population."

Nearly all treated patients (98.8%) saw TR grade drop from severe, massive, or torrential down to moderate or less, compared with 21.6% among those on optimal medical therapy alone at 6 months (P<0.001). And 77.8% of the intervention group had no more than trace TR at 6 months.

Moreover, "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 noted in the statement.

Since the TCT presentation, 318 of the total 392 randomized patients completed a 1-year visit for the main trial endpoint analysis. "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 [Kansas City Cardiomyopathy Questionnaire quality of life scores], NYHA [New York Heart Association class] and 6MWD [6-minute walk distance]," the company release noted.

Edwards said it expects presentation of the full cohort 1-year results of TRISCEND II at TCT in October 2024.

Another tricuspid regurgitation-targeted transcatheter therapy -- edge-to-edge repair with the TriClip device -- is under FDA review as well, offering the potential for multiple options in the therapeutic armamentarium for inoperable TR patients.

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