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News From the Food and Drug Administration
January 3, 2017

Reducing Recurrent Strokes

JAMA. 2017;317(1):18. doi:10.1001/jama.2016.19075

A device that reduces the risk of a second stroke in patients whose first may have resulted from a blood clot traveling through a patent foramen ovale (PFO) and on to the brain has received FDA approval.

The Amplatzer PFO Occluder is inserted through a catheter placed in a leg vein and then implanted between the right and left atria to seal the PFO. Previous studies hadn’t shown conclusively whether closing the PFO could prevent a subsequent stroke in patients who had had a cryptogenic ischemic stroke. So investigators from 7 US clinical centers launched a trial to find a more definitive answer.

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