Officials with the U.S. Food and Drug Administration (FDA) recently accepted the new Amplatzer PFO Occluder device to reduce the chances of recurring strokes in specific patients.
Qualifying patients must have had a stroke because of a blood clot traveling through the heart via a small hole, or a patent foramen ovale (PFO). For selected individuals, this clot then traveled through the brain, causing a stroke.
An estimated 25-30 percent of Americans have PFOs, which do not cause any health problems until a stroke occurs. PFOs do not require treatments; however, strokes are more likely as a result.
"The Amplatzer PFO Occluder provides a nonsurgical method for doctors to close a PFO," Dr. Bram Zuckerman, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said. "But, as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke."
Most people experience strokes because of narrowed blood vessels from cholesterol deposits, badly controlled blood pressure, scar tissue blocking blood vessels (atherosclerosis), or a blood clot from an abnormal heart rhythm (atrial fibrillation). Unfortunately, the cause of strokes is not always obvious.
