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Abbott Wins FDA Approval For TriClip Repair System, Compete Against Edwards

Executive Summary

Abbott wins FDA approval for TriClip regurgitation therapy, which will compete against Edwards Lifesciences’ recently approved Evoque transcatheter tricuspid valve replacement device. Two analysts expect Tricuspid will be eligible for a new technology add-on payment, which will be positive for Abbott.

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Abbott Moves Forward With TriClip G4 TTVR After Successful Advisory Panel

After an FDA advisory panel voted in support of Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device, Medtech Insight discussed the panel’s review with Barathi Sethuraman, DVP for clinical affairs for Abbott’s structural heart business.

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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