TriClip Gets AdComm Thumbs-Up for Tricuspid Regurgitation

Despite FDA skepticism, the agency’s Circulatory System Devices Panel advisory committee endorsed Abbott’s TriClip, a transcatheter edge-to-edge repair system intended to treat tricuspid regurgitation.

The 14-member panel unanimously agreed that the device was safe, but split on its efficacy, with two members voting no. On the question of whether TriClip’s risks outweighed its benefits, Paul Hauptman, Dean of the University of Nevada, Reno, School of Medicine, was the sole dissenter.

In its background document, FDA reviewers raised the possibility of placebo-effect skewing patient-reported outcomes data in Triluminate, the device’s pivotal trial.

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