FDA Advisory Panel Gives Abbott TriClip System Thumbs Up

FDA’s Circulatory System Devices Panel ruled yesterday that the benefits of Abbott Laboratories’ TriClip transcatheter tricuspid valve repair system outweighed the risks in treating tricuspid regurgitation (TR).

Abbott submitted the system to FDA for premarket approval in March 2023. The company has now updated its timeline for the approval to some point this year, with the panel’s vote being considered when making the final decision. Of note, the last two products reviewed by the Circulatory System Devices Panel saw FDA approval about two to three months after the panel meeting.

The TriClip system is indicated for use in patients with symptomatic severe TR who saw negligible improvement through treatment with medical therapy. These patients are at an intermediate or greater risk for surgery and are appropriate candidates for tricuspid valve edge-to-edge repair, according to Abbott.

TR occurs when the tricuspid valve doesn’t close properly, leading to a leak that allows blood to flow backward into the heart. Patients with this condition can experience fatigue, shortness of breath, irregular heart rhythms, swelling, and organ dysfunction. As TR progresses, it often becomes debilitating, severely impacting patient’s quality-of-life (QOL).

The TriClip transcatheter edge-to-edge repair (TEER) technology is delivered through a vein in the leg and clips together a portion of leaflets to repair the tricuspid valve which helps blood flow in the correct direction without need for open-heart surgery.

"Tricuspid regurgitation can put added strain on the heart and lead to other cardiovascular issues, which can significantly worsen a person's quality of life, but historically there have been few treatment options,” said Lars Søndergaard, MD, chief medical officer and divisional vice president of medical affairs of Abbott's structural heart business, in statement sent to MD+DI. “Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery."

In a 13 to one vote, the advisory committee decided in favor of the system’s benefits, also voting on its safety and effectiveness profile. For safety, the panel voted 14 to zero supporting the existence of enough data. For the question of reasonable assurance of effectiveness, the panel voted 12 to 2 in favor.

The panel based its decision on clinical data from Abbott’s Triluminate pivotal trial and expert testimony.

The clinical trial evaluated 572 randomized patients and those enrolled in the concurrent single-arm group. Key findings through one year illustrated safety, effectiveness, and benefits of using TriClip. Additionally, the single-arm group, which was filled with patients with more complex tricuspid valve anatomy and advanced disease, met its primary endpoint. Safety data showed that 81% of patients achieved TR reduction to moderate or less with TriClip — a similar QOL improvement compared to the randomized patients.

The panel discussed potential limitations surrounding the study, including the KCCQ score, which was the driver of it meeting primary effectiveness endpoints, and the higher win ratio result in high-enrollment sites. Even so, the panel remained largely favorable, according to BTIG analysts.

“Most individuals felt KCCQ was a valid measure and that the placebo effect did not account for all the improvements,” wrote analysts Marie Thibault and Sam Eiber. “Panelists were comforted by early and sustained improvements out to 12 months, the relationship between change in TR and KCCQ and an imaging sub-group analysis that showed reverse remodeling. It was opined that these results did not translate into statistically significant improvements in heart failure hospitalization and mortality because of the lower-risk patient population enrolled in the study and the early follow-up.”

Additionally, the one holdout on the risk-benefit decision said he needed more information or a better definition on which patients would benefit the most. He indicated that he may have voted yes if the proposed instructions for use (IFU) had a narrower scope.

Regardless, Thibault and Eiber wrote that “the overwhelming favorable vote gives us increased confidence the FDA will approve TriClip in the coming months.”

TriClip currently holds approval in more than 50 countries, with its most recent CE Mark being obtained in 2021. If approved in the United States, it would accompany the recently approved Edwards Evoque Tricuspid valve, which became the first transcatheter therapy approved to treat TR early in February.