Cardio Catch-Up: FDA Approves Edwards Evoque Transcatheter Tricuspid Valve Sooner Than Expected

 
• By Reed Miller

Edwards' Evoque is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. The FDA-approved labeling says it can improve patients' "health status" but the company may be able to soon upgrade that indication to include a mortality benefit claim, which could give Evoque an important advantage over tricuspid valve repair devices.

Edwards' Evoque transcatheter tricuspid valve
• Source: Edwards Lifesciences

The US Food and Drug Administration approved Edwards Lifesciences’ Evoque tricuspid valve replacement system to improve the “health status” of people with symptomatic severe tricuspid regurgitation.

The approval, announced on 1 February, makes Evoque the first FDA-approved transcatheter tricuspid replacement valve. Evoque earned FDA's breakthrough status in 2019 and a CE mark in October 2023

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