The FDA expert advisory panel votes are in, and they’re pointing in an overwhelmingly positive direction for Abbott’s TriClip tricuspid edge-to-edge repair (TEER) treatment.
- The TriClip G4 is intended to treat tricuspid regurgitation by clipping together a portion of a patient’s tricuspid valve leaflets to keep blood from leaking from the right ventricle into the atrium.
The FDA’s Circulatory System Devices expert panel analyzed available TriClip data, voting 13-1 that the device’s benefits outweigh its risks for patients with severe tricuspid regurgitation, including a 12-2 vote supporting its effectiveness and a 14-0 vote for its safety.
Those results might have caught some interventionalists and FDA-watchers off guard, noting that their previously-released source documents seemed to highlight the fact that that TriClip’s pivotal TRILUMINATE study only showed clear benefits for patients’ quality of life, but no benefits for HF hospitalization or mortality, and it was open-label (so prone to placebo effect).
- Those concerns were echoed online after the FDA panel votes became public, with criticisms largely aligning with the concerns in the panel documents (only QoL, placebo effect) and suggesting that the data doesn’t justify a 13-1 vote.
Regardless, the FDA panelists largely supported quality of life as an important TR metric and were impressed with the TriClip’s safety profile, with one panelist explaining that “if we can help symptoms at a low cost in terms of risk, it makes a lot of sense.”
- The fact that the TriClip has already been approved in over 50 countries and has been used in over 10k patients probably helps too.
The TriClip’s strong panel vote continues a recent hot streak for trancatheter-based TR treatments, coming just a week after the FDA approved Edwards’ EVOQUE transcatheter tricuspid valve replacement system, potentially giving interventionalists the options to repair or replace the tricuspid valve if/when the TriClip is approved.
- That streak started much earlier in Europe, where the TriClip has been approved since 2020, and Edwards already markets its Pascal and Cardioband TR valve repair systems.
- TR’s hot streak could also continue, as the Pascal system is approaching the end of its CLASP II TR pivotal trial, and a range of other TR systems are in development.
The Takeaway
One week ago, the US had no transcatheter TR therapies, and now it appears that we are on the way to having two. Regardless of how you view the panel’s decision making process, this is a big deal for TR treatments, and could lead to big changes for TR patients and their care teams.
