Abbott Receives FDA Approval for TriClip, a Medical Device for Repairing Tricuspid Regurgitation

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The FDA has approved Abbott’s TriClip device, a treatment designed to repair tricuspid regurgitation (TR), also described as a leaky tricuspid heart valve. According to the company, this approval offers patients a new, minimally invasive treatment option. The device operates by utilizing transcatheter edge-to-edge repair (TEER) technology to clip together parts of the valve's leaflets. As a result, hospital recovery time has the potential to be reduced to one day.

The approval was based on results from the TRILUMINATE Pivotal trial, which found that 90% of patients treated with the TriClip device reported improvements in their TR grade that were sustained for a year. Further, 98% of those patients who received the device were free of any severe adverse events after 30 days.¹

"The US approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," co-principal investigator of the TRILUMINATE trial Paul Sorajja, MD, the Roger L. and Lynn C. Headrick Family Chair, Valve Science Center, Minneapolis Heart Institute Foundation, director, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, said in a press release. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness 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."

Last year, Abbott presented key findings from the TRILUMINATE study, which also found major quality of life improvements. Half of the patient group achieved a minimum of a 15-point improvement based on the Kansas City Cardiomyopathy Questionnaire (KCCQ). The results were also presented at the American College of Cardiology's 72nd Annual Scientific Session with World Congress of Cardiology.²

"These TRILUMINATE Pivotal data show TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms," said Michael Dale, SVP, Abbott's structural heart business, in a press release. "When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love."

Tricuspid valve repair is required as a result of tricuspid valve disease, which has two variants: tricuspid valve stenosis and tricuspid valve regurgitation. Common symptoms include fatigue, swelling in the legs, and an abnormal heart rhythm.³

"This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions," said Sandra Lesenfants, SVP, Abbott's structural heart business, in the press release. "With the addition of TriClip to our broad structural heart therapy offerings in the US, we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions."

References

1. ABBOTT RECEIVES FDA APPROVAL FOR TRICLIP™, FIRST-OF-ITS-KIND DEVICE TO REPAIR LEAKY TRICUSPID HEART VALVE. Abbott. April 2, 2024. Accessed April 3, 2024. https://abbott.mediaroom.com/2024-04-02-Abbott-Receives-FDA-Approval-for-TriClip-TM-,-First-of-Its-Kind-Device-to-Repair-Leaky-Tricuspid-Heart-Valve

2. NEW DATA SHOW SUPERIORITY OF ABBOTT'S TRICLIP™ DEVICE COMPARED TO MEDICAL THERAPY FOR TRICUSPID REGURGITATION. Abbott. March 4, 2023. Accessed April 3, 2024. https://abbott.mediaroom.com/2023-03-04-New-Data-Show-Superiority-of-Abbotts-TriClip-TM-Device-Compared-to-Medical-Therapy-for-Tricuspid-Regurgitation

3. Tricuspid Valve Replacement and Repair. Hopkins Medicine. Accessed April 3, 2024. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/tricuspid-valve-replacement-and-repair