FDA Approves Device to Prevent Recurrent Strokes in PFO Patients

Share this content:
FDA Approves Device to Prevent Recurrent Strokes in PFO Patients
FDA Approves Device to Prevent Recurrent Strokes in PFO Patients

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.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Potentially Unsafe Med Scripts Up for Dual Users With Dementia

Potentially Unsafe Med Scripts Up for Dual Users ...

Rates of PUM are higher among veterans with dementia using VA-Medicare Part D system

Menopausal Status Linked to Faster Lung Function Decline

Menopausal Status Linked to Faster Lung Function Decline

Transitional, postmenopausal women have increases in adjusted mean forced vital capacity decline

Social Media Rarely Used by Plastic Surgeons

Social Media Rarely Used by Plastic Surgeons

6 percent of posts about plastic surgery by plastic surgeons; 37 percent of these self-promotional

is free, fast, and customized just for you!

Already a member?

Sign In Now »