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This protocol is part of an Individual Patient Expanded Access IND. The patient is an 84-year-old male with history of Ischemic Stroke of the Left Middle Cerebral Artery causing an acute posterior left frontal cortical infarct with petechial hemorrhage and mild local mass effect without midline shift. The Stroke was due to a long-standing evolution of atrial fibrillation that provoked an embolus. The original stroke event happened on February/14/2022.
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.