Abbott Gets FDA Approval for TriClip Heart Valve Repair System
By Chris Wack
Abbott said the U.S. Food and Drug Administration has approved its first-of-kind TriClip transcatheter edge-to-edge repair system that is specifically designed for the treatment of tricuspid regurgitation, or a leaky tricuspid valve.
The company said this approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with no abstentions, that the benefits of TriClip outweighed the risks.
Abbott said that, 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. On average, people who receive TriClip only need one day in the hospital before they recover and can return home.
The trial demonstrated 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.
TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 02, 2024 09:45 ET (13:45 GMT)
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