After several years of evaluation, St. Jude Medical’s AMPLATZER PFO Occluder has received approval from the FDA to help reduce the risk of recurrent ischemic strokes in patients with a small opening between the upper chambers of the heart, called a patent foramen ovale (PFO).

In a developing fetus, the foramen ovale enables oxygenated blood from the placenta to bypass the lungs and it usually closes after birth. However, when it remains open it can potentially allow clots to travel from the right side of the heart to the left, then to the brain, ultimately triggering a stroke.

The device was proven to be safe and effective in an eight-year randomized study that evaluated 499 individuals between ages 18 and 60 who were treated with the device and blood-thinning medications, and 481 who were treated with only the medications.
The AMPLATZER PFO Occluder is the only approved device that seals that opening between the left and right chambers of the heart, according to St. Jude Medical. It takes only about one hour to complete the procedure, it can be performed with conscious sedation and it reduces the patients’ risk of having another stroke by 50 percent.

The device is inserted through a catheter and is placed in a leg vein and moved to the heart. It’s then implanted close to the hole in the heart between the top right chamber and the top left chamber.

On May 24, doctors on the FDA’s Circulatory System Devices Panel voted 15 to one that it was safe to use. The panel voted nine to seven on its effectiveness and 11 to five on whether the potential benefits outweigh the risk, according to a report by TCTMD.

Most of the interventional cardiologists on the FDA panel voted for recommending approval but several neurologists voted that it’s not effective.

The device had been on the market over a decade ago under a humanitarian device exemption (HDE), but it was voluntarily taken off the market by the manufacturer in 2006 when the FDA found that the target population for the device was more than 4,000 patients and that it was no longer qualified for an HDE approval.

The FDA cautions that patients should discuss the risks and benefits of PFO closure in comparison to using medications alone with their medical team.

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

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