PFO Occluder Approved to Reduce Risk of Recurrent Stroke

Monday, October 31, 2016 | FDA Approval/Clearance , Stroke & Cerebrovascular


The FDA recently approved St. Jude Medical’s Amplatzer PFO Occluder to help reduce the risk of recurrent ischemic strokes in patients diagnosed with a patent foramen ovale (PFO). The Amplatzer PFO is the only device approved in the US for PFO closure and has been shown to reduce their risk of recurrent stroke of stroke by sealing the unwanted hole between the left and right chambers of the heart. Data from the RESPECT trial, an eight-year clinical study of nearly one thousand patients diagnosed with both PFO and cryptogenic stroke, demonstrated PFO closure provides a clinically meaningful patient benefit over medical management alone, and that PFO closure with the AMPLATZER PFO Occluder reduced the risk of recurrent stroke by over half compared to standard medical treatment.

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