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