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# Abbott's TriClip OK'd for Tricuspid Regurgitation
- URL: https://www.fdaweb.com/abbotts-triclip-okd-for-tricuspid-regurgitation/
- Published: 2024-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:27:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156699

FDA has approved Abbott’s TriClip, which it describes as a “first-of-its-kind” transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation (leaky valve).

Approval is based in data from the TRILUMINATE Pivotal trial that evaluated the safety and effectiveness of the TriClip system compared to medical therapy in people with severe tricuspid regurgitation (TR) who are at intermediate or greater risk for open-heart surgery. “In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year,” Abbott says. The trial also showed a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life, it adds.

The tricuspid valve controls the heart’s blood flow from the right atrium to the right ventricle. TR happens when the valve fails to close properly, which causes a leak that allows blood to flow backward into the heart, the company says, adding that TR can force the heart to work harder, causing fatigue and shortness of breath. If left untreated, it can result in atrial fibrillation, heart failure and death.