An advisory panel to the US Food and Drug Administration (FDA) on Wednesday cautiously backed approval of a filtering device intended to trap emboli and minimize the risk of neurological and other complications associated with coronary aortic bypass graft (CABG) procedures.
The device, developed by privately held A Med/Embol-X Inc. of West Sacramento, California, is a cannula with a distal heparin-coated mesh filter designed to remove the cholesterol crystals and calcified plaque that can be dislodged during the unclamping of the aorta.
Without taking a formal vote, the FDA’s Circulatory System Devices Advisory Committee endorsed the company’s belief that filtering this debris could result in a clinical benefit for high-risk patients, such as those over 60 years old and those with atherosclerosis.
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