The U.S. Food and Drug Administration (FDA) on Oct. 28 approved the Amplatzer PFO Occluder device for the prevention of recurrent strokes in some patients. The device offers a non-surgical option to reduce the risk of strokes in patients who previously suffered a stroke due to a blood clot passing through a patent foramen ovale (PFO) to the brain. Previously on the market under a humanitarian device exemption and voluntarily withdrawn after the target population grew too large, the most recent study demonstrated a 50 percent reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder. The device is now the only FDA-approved heart occlude device available specifically intended to close PFOs in order to reduce the risk of a recurrent stroke following a cryptogenic stroke.

Read more on the approval here.

Keywords: Brain, Cerebral Infarction, Compassionate Use Trials, Septal Occluder Device, Stroke, United States Food and Drug Administration

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