FDA Update: Agency Approves Abbott TriClip to Treat TR

The U.S. Food and Drug Administration has approved on April 2 the Abbott TriClip™, a transcatheter edge-to-edge repair (TEER) system specifically designed for the treatment of tricuspid regurgitation (TR), according to an Abbott press release.

The first-of-its-kind device provides a minimally invasive treatment option for patients in need of tricuspid valve repair. Before approving the device, the FDA reviewed results from the TRILUMINATE Pivotal trial, presented at ACC.23/WCC, which found that tricuspid TEER was safe for patients with severe TR, reduced the severity of TR and was associated with an improvement in quality of life.

Clinical Topics: Valvular Heart Disease

Keywords: United States Food and Drug Administration, Transcatheter Cardiovascular Therapeutics, Structural Intervention, Heart Valve Diseases, ACC Advocacy

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