Abbott (ABT) said that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration confirmed 13 to 1, with 0 abstention that the benefits of Abbott's TriClip transcatheter edge-to-edge repair or TEER system outweighed the risks for the treatment of people with tricuspid regurgitation.
The panel's decision was based on clinical data from the TRILUMINATE pivotal trial, as well as expert testimony.
Abbott said it submitted its pre-market approval (PMA) application for the TriClip device in March 2023 to the FDA, which lead to today's advisory committee panel for expert advice on the device's clinical safety, effectiveness, risk and benefit. The FDA routinely seeks input from advisory committees, especially for first-of-a-kind medical devices. The FDA's decision on Abbott's TriClip is expected in 2024.
TriClip is approved for use in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with tricuspid regurgitation. It is an investigational device in the United States.
The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. Tricuspid regurgitation occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. For those who continue to have symptoms or persistent tricuspid regurgitation despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents a potentially new option that can improve a person's quality of life, Abbott said.
Delivered through a vein in the leg, TriClip's TEER technology works by clipping together a portion of the leaflets - or flaps of tissue - to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery.
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