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FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR

12 Feb 2024

An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.

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[Editor's Note: At its 14 February meeting, FDA's circulatory system devices panel voted nearly unanimously in favor of Abbott's TriClip G4, including a 13-1 vote in favor of concluding that the benefits of the technology outweigh its risks. Medtech Insight will have more on TriClip G4 later this week.]

Analysts expect the US Food and Drug Administration to approve Abbott ’s TriClip G4 transcatheter tricuspid valve repair (TTVR)...