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FDA approves Amplatzer PFO Occluder device for prevention of recurrent strokes
Today, the US Food and Drug Administration (FDA) approved St. Jude Medical's Amplatzer PFO Occluder device for recurrent stroke prevention in patients with a patent foramen ovale (PFO) and history of cryptogenic stroke. This comes after the RESPECT clinical trial, published in the New England Journal of Medicine in 2013, showed no benefit of the device in this cohort of patients. However, long-term follow-up studies showed the device cut the risk of recurrent stroke.