New Device Approved By FDA for Prevention of Recurrent Strokes in Some Patients by 30Seconds Health

The U.S. Food and Drug Administration (FDA) has approved the Amplatzer PFO Occluder device, which reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. The device is inserted through a catheter that is placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the top right chamber (right atrium) and the top left chamber (left atrium).

“The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO,” said Dr. Bram Zuckerman, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “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.”

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