FDA Approves TriClip TEER Device for Tricuspid Repair

(UPDATED) The approval was based on positive data from the TRILUMINATE pivotal trial, which included a highly symptomatic population.

FDA Approves TriClip TEER Device for Tricuspid Repair

The US Food and Drug Administration has approved the TriClip device for transcatheter edge-to-edge repair (TEER) in patients with tricuspid regurgitation (TR) who are not candidates for surgery, the manufacturer Abbott announced today.

In February, the FDA’s Circulatory System Devices Panel voted 12-2 in favor of TriClip’s efficacy, and 14-0 on its safety. The approval is based on strong data from the TRILUMINATE pivotal trial showing that compared with those on medical therapy alone, TriClip patients had a more favorable primary composite outcome (all-cause death or tricuspid valve surgery, hospitalization for heart failure, and improvement in quality of life) after 1 year.

TRILUMINATE patients had symptomatic severe TR and were deemed to have at least an intermediate risk for mortality with tricuspid valve surgery. All were stable on guideline-directed medical therapy and/or device therapy for heart failure.

In a press release, TRILUMINATE’s co-principal investigator Paul Sorajja, MD (Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, MN), called the approval a significant advancement for patients with tricuspid regurgitation “to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."

Speaking with TCTMD, the study’s other co-principal investigator David Adams, MD (Icahn School of Medicine at Mount Sinai, New York, NY), noted that even when surgery is feasible, the mortality rate is in the 10-15% range in contemporary practice.

“This really is ushering in a new era of tricuspid valve intervention,” he said. “I think that you'll see the pendulum change now and . . . this disease process will be treated much earlier in patients that may have failed medical therapy, which is going to show us even bigger gains in terms of outcomes.”

TriClip, the sponsor notes, has received CE Mark approval in 2020 and is available in more than 50 countries.

Two Options, One Patient Group

With both TriClip and Evoque (Edwards Lifesciences), the first transcatheter tricuspid valve replacement device, now approved in the US, Adams said it will be interesting to see how the two will be used by heart teams.

“We will learn a lot in the next few years because this therapy is going to expand rapidly,” he added. “[With] replacement strategies, including with Evoque, as well as TEER strategies, we will continue to improve and make progress in many areas, including imaging [and] that will make these therapies even safer.”

It will be up to heart teams to evaluate patients carefully, with full understanding of the tricuspid anatomy in order to decide whether the extra risk associated with valve replacement and anticoagulation are warranted, he noted.

In Europe, the pattern so far has been to determine if a good result is possible with TEER therapy and if not, to move on to replacement. Adams said he would expect that pattern to dominate in the US as well.

Interestingly, the indication for Triclip is slightly narrower than for Evoque. Evoque was approved without an FDA advisory committee meeting and was approved based on a preliminary dataset, yet given a wider indication, with no mention of patients needing to be at high risk for surgery.

By contrast, TriClip did undergo advisory panel review and had full trial results to support its approval, from TRILUMINATE. Nonetheless, labeling specifies that it is indicated for “improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.”

Adams said while the indications for the two new devices may read differently, he believes the subgroup of patients who will be treated by both devices will be the same.

“I'm sure some interventional teams will favor one treatment over the other [and] the reality is most patients want to keep their own heart valves if they can. If you have the anatomy where you can get a good result with a TriClip, I do think in most structural valve centers that will be the primary goal,” he said. Replacement will likely be a fallback if symptoms don’t improve after TEER. “But again,” he said, “we're just beginning this journey.”

  • Abbott. Abbott receives FDA approval for TriClip, first-of-its-kind device to repair leaky tricuspid heart valve. Published and accessed on: April 2, 2024.