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Majority of FDA Advisers Give Green Light to Amplatzer PFO Closure Device for Stroke

from TCTMD

Patent foramen ovale closure using the Amplatzer device for the prevention of recurrent stroke should be approved as an option for patients with cryptogenic stroke, the majority of a team of experts assembled by the Food and Drug Administration agreed. The mixed vote comes after two decades of controversy, failed trials and abandoned devices for a strategy that all but the most enthusiastic operators had stepped away from, given the apparent futility of studies that have sought to show a benefit for the therapy. more


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