Abbott’s TriClip Earns PMA Approval to Repair Leaky Tricuspid Heart Valve

Abbott announced FDA approval of the company’s TriClip transcatheter repair system designed for the treatment of tricuspid regurgitation, or a leaky tricuspid valve.

The approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee, that unanimously agreed that the device was safe, but split on its efficacy, with two members voting no.

Delivered through a vein in the leg, TriClip 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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