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February 13, 2024 | TCTMD

The advisory committee took a hard look at the TRILUMINATE data and concluded the benefits of TriClip outweigh the risks.

By Michael O'Riordan

Expert advisors to the US Food and Drug Administration offered little in the way of pushback against the TriClip (Abbott) transcatheter edge-to-edge repair (TEER) system as a treatment for symptomatic severe tricuspid regurgitation (TR).

By the end of yesterday’s advisory meeting, the Circulatory System Devices Panel’s take was overwhelmingly favorable, with members voting 13-1 that the benefits of TriClip outweighed the risks for use in patients who meet the proposed indication criteria. The panel voted 12-2 that TriClip was effective and voted 14-0 that there were reasonable assurances the device was safe.

Interventional cardiologist James Blankenship, MD (University of New Mexico, Albuquerque), who voted in favor of the device, said he was impressed with the improvement in quality of life seen in the pivotal trial. “The safety profile looks good compared to a lot of things that many of us do, [so] I have a lower bar for efficacy,” said Blankenship. “Even if it’s only helping symptoms, that’s what total hip replacements do—they help symptoms—so if we can help symptoms with [TriClip] at a low cost and low risk, I think it makes a lot of sense.”

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Page Created: April 26, 2024 Last Updated: April 26, 2024