The Amplatzer PFO Occluder device has been approved by the U.S. Food and Drug Administration to prevent another stroke among people who had at least one prior stroke involving a PFO (patent foramen avale).
A PFO is a small hole in the heart that could allow passage of a blood clot.
Up to 30 percent of Americans have a PFO, the FDA explained in a news release. The condition typically causes no health issues and doesn’t require treatment.