FDA Approves Device to Prevent Recurrent Strokes in PFO Patients
For patients who had prior stroke related to patent foramen ovale
FRIDAY, Oct. 28, 2016 (HealthDay News) -- The Amplatzer PFO Occluder device has been approved by the U.S. Food and Drug Administration to prevent another stroke among patients who have had at least one prior stroke involving a patent foramen ovale (PFO).
The new device is inserted via a catheter in a leg vein and is advanced to the heart. The approval followed clinical testing of the device's safety and effectiveness among more than 900 participants, aged 18 to 60 years. Those who used the device plus anticoagulants were 50 percent less likely to have a new stroke, compared with those who took anticoagulants alone, the FDA said.
Potential side effects of the device include heart injury, atrial fibrillation, or blood clot at the implant site. People with abnormal connections between the heart's chambers or in whom unusual cardiovascular anatomy might inhibit the device's implantation shouldn't use the device, the FDA said.
"The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO," Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said in a statement. "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."
The device is produced by St. Jude Medical, based in Plymouth, Minn.