Abbott Laboratories (ABT) announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve.
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, that the benefits of TriClip outweighed the risks.
The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. 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.
TriClip leverages the same clip-based technology as Abbott's leading MitraClip device.
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