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