The US Food and Drug Administration (FDA) has approved Abbott's TriClip Transcatheter Edge-to-Edge Repair (TEER) system to repair severe tricuspid regurgitation (TR), the company has announced. 

By Megan Brooks

The approval follows the recent vote in favor of TriClip by the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee. The vote was 13 to one, with zero abstention, that the benefits of TriClip outweigh the risks.

The committee's decision and FDA approval was based on results of the randomized controlled TRILUMINATE trial.

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