An advisory committee to the US Food and Drug Administration has voted in favor of Abbott's TriClip transcatheter edge-to-edge repair (TEER) system for repair of severe tricuspid regurgitation (TR).
The thumbs up by the Circulatory System Devices Panel of the Medical Devices Advisory Committee was based in large part on data from the TRILUMINATE trial.
Conducted at 65 centers in the United States, Canada, and North America, the trial enrolled 350 patients with severe TR who were randomly allocated (1:1) to TEER performed with the TriClip delivery system or medical therapy (control).
As previously reported by theheart.org | Medscape Cardiology, patients who underwent repair with the TriClip TEER system experienced a large reduction in valve dysfunction, which was associated with substantial improvement in quality of life that persisted out to 1 year of follow-up.
TriClip TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.
The study results were presented last year at the joint scientific sessions of the American College of Cardiology/World Congress of Cardiology and published in The New England Journal of Medicine.
All 14 advisory panel members felt the data were adequate to support the safety of the device.
In explaining his yes vote on safety, Bradley Bart, MD, codirector of the heart failure program, at Minneapolis VA Medical Center, Minneapolis, Minnesota, said that "overall, the totality of the evidence is favorable. And it's important to consider what the alternatives are for these patients, and their alternatives are quite limited."
James Blankenship, MD, director, Division of Cardiology, University of New Mexico, Albuquerque, New Mexico, noted that the safety profile "looks good and even if it's only helping symptoms, which is what total hip replacements do; if we can help symptoms with this [device] at a low cost in terms of risk, I think it makes a lot of sense."
In the trial, at 30 days, 87.0% of the patients in the TEER group had TR no greater than moderate severity (P < .001) vs 4.8% of those in the control group. The incidence of death or tricuspid valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups.
On the second question of whether there is reasonable assurance that the device is effective, the panel voted 12 to 2 in favor.
Paul Hauptman, MD, professor of medicine, University of Nevada, Reno School of Medicine, Reno, Nevada, who voted yes on safety, voted no on this efficacy question. "I just felt the need to pull back a little bit on unbridled enthusiasm because I think we have a responsibility to better understand who is going to benefit and that needs better definition."
Marc Katz, MD, MPH, chief, Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston, South Carolina, voted yes on safety, no on efficacy, but in the end voted "yes for the benefits outweighing the risks" — which was the last question put to the panel.
Katz noted that TriClip TEER is "going to have to find its niche" and emphasized that training on imaging is "going to be crucial for this because imaging the tricuspid valve is not as simple as imaging the mitral valve."
According to Abbott, TriClip is approved in more than 50 countries, including in Europe and Canada, and has been used to treat more than 10,000 people with TR. The device remains investigational in the United States.