Oct 28 (Reuters) - The U.S. Food and Drug Administration said on Friday it approved St. Jude Medical Inc's device to reduce the risk of a second stroke in some patients who have already had a stroke.
The device, called the Amplatzer PFO Occluder, reduces the risk of stroke in patients whose previous stroke is believed to have been caused by a blood clot that passed through a small hole in the heart to the brain.
The device offers a non-surgical method for doctors to close the hole in the heart, known as a patent foramen ovale, the FDA said. About 25 percent to 30 percent of Americans have a PFO that typically does not cause problems and does not require treatment, the FDA said.
"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," said Dr. Bram Zuckerman, director of cardiovascular devices in the FDA's devices division.
The device is inserted through a catheter placed in a leg vein and snaked to the heart. It is implanted to close the hole. Possible adverse events include injury to the heart, blood clots in the heart, leg or lung, rapid heart rate and stroke.
(Reporting by Toni Clarke in Washington; Editing by Steve Orlofsky)