The approval follows an FDA advisory committee vote in favor of Abbott's TriClip Transcatheter Edge-to-Edge Repair system for repair of severe tricuspid regurgitation.
An FDA advisory panel voted 13 to 1 that the benefits of Abbott's first-of-its-kind transcatheter system to treat tricuspid regurgitation outweigh any potential risks.
Edwards Lifesciences received approval for its Evoque tricuspid valve replacement system, the first transcatheter therapy approved in the US for tricuspid regurgitation.
TRILUMINATE, the first pivotal trial of a device for repair of severe tricuspid regurgitation, showed a large reduction in valve dysfunction associated with substantial improvement in quality of life.