FDA Approves PFO Occluder Device to Prevent Recurrent Strokes in Some Patients

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 Previously on the market under a humanitarian device exemption and voluntarily withdrawn after the target population grew too large, the most recent study demonstrated a 50 percent reduction in the rate of new strokes in participants using the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.

Clinical Topics: Vascular Medicine

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

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