FDA Approves TriClip TEER System for Tricuspid Regurgitation
Less than 2 months after being the subject of an FDA AdComm meeting, Abbott's TriClip TEER System has received approval for tricuspid regurgitation.
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Less than 2 months after being the subject of an FDA AdComm meeting, Abbott's TriClip TEER System has received approval for tricuspid regurgitation.
The approval was based on positive data from the TRILUMINATE pivotal trial, which included a highly symptomatic population.
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.
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FDA panel confirms support (13-1) for Abbott Laboratories' TriClip TEER system in treating tricuspid regurgitation. Approval decision expected from FDA in 2024.