The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

The device – which was marketed more than a decade ago under a humanitarian device exemption (HDE) but was voluntarily withdrawn by St. Jude in 2006 after FDA concluded that the target population for it was greater than 4,000 patients – is specifically for such patients who previously had a stroke that was 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.

Since 2006 (when the device was pulled from the market), this is the first FDA-approved heart occluder device specifically indicated to close PFOs to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke, which is a type of stroke where medical tests cannot identify the cause.

“The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO,” said Bram Zuckerman, M.D., 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.”

How it Works

The Amplatzer PFO Occluder 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).

FDA said the device should not be used in patients with a heart valve infection or other untreated infections, or a heart tumor or blood clot at the implant site. The device is also contraindicated in patients with other abnormal connections between the heart chambers or in whom the cardiovascular anatomy or blood clots would interfere with the ability to move the catheter. 

Trials for Approval

FDA concluded that the device demonstrated a reasonable assurance of safety and effectiveness after a randomized study evaluated 499 participants aged 18 to 60 who were treated with the Amplatzer PFO Occluder plus blood-thinning medications and were compared to 481 participants who were treated with only blood-thinning medications.

While the rate of new strokes in both treatment groups was very low, FDA said, the study found a 50% reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder plus blood-thinning medications compared to those only taking blood-thinning medications.