May 27, 2016 — A U.S. Food and Drug Administration (FDA) panel recommended approval of a transcatheter patent foramen ovale (PFO) occluder to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
The FDA’s Circulatory System Devices Panel met May 24 to discuss the merits of a premarket approval (PMA) application for St. Jude Medical’s Amplatzer PFO Occluder System. The panel voted to recommend approval to the FDA, but there were questions about the device and supporting data from several panel members.Â
