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

 
• By Marion Webb

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.

Heartvalve
• Source: Shutterstock

Abbott announced on 2 April that it has received US Food and Drug Administration approval to market its TriClip G4 system for repairing a leaky tricuspid valve, a condition that the company says affects about 1.6 million people in the US.

The approval comes after a 13 February meeting of the FDA’s circulatory system panel endorsed TriClip G4 for treating severe tricuspid regurgitation (TR), voting 13-1 to affirm that the benefits of the system outweigh risks for the intended population

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