TUESDAY, June 11, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a procedure to treat what is technically known as a "patent foramen ovale" (PFO). The more common term is "hole in the heart," and it is more widespread than you might imagine.
The FDA has given the go-ahead to the AGA Medical Corp. of Golden Valley, Minn. to market the Amplatzer PFO Occluder, which in effect, is a plug to close an abnormal opening in the wall between the two upper chambers of the heart. The Occluder causes a clot to form, which closes the hole and eventually becomes part of the wall of the heart.
A catheter is used to thread the Occluder to the defect in the heart wall. It's then opened, and a mesh disc creates the "clot" that eventually will allow strong tissue to grow.
While scientists are still determining whether there's a cause-and-effect relationship between those who have PFO and their likelihood of having a stroke, research shows a great number of stroke victims also have had the patent foramen ovale.
About 750,000 strokes occur annually in the United States, and of those, an estimated 90,000-200,000 may have been caused by blood clots from PFO.
PFO develops when a flap in the passageway between the lungs and the heart doesn't close in infancy as it does in 90 percent of the U.S. population.
This FDA site provides more information about the PFO Occluder.
