FDA Approves Stroke Prevention Device

The FDA recently approved the Amplatzer PFO Occluder device to reduce risk factors in patients who have previously experienced a stroke.

The device prevents strokes in patients whose first stroke was caused from a blood clot that passed through a patent foramen ovale in the heart and traveled to the brain, according to the FDA.

Approximately 25% to 30% of Americans have a patent foramen ovale, which is a small hole in the heart. This condition typically does not cause health issues, nor does it require treatment in most cases.

A majority of strokes are caused from high blood pressure, narrowed blood vessels from cholesterol deposits and atherosclerosis, or a clot from atrial fibrillation, according to the FDA. Other patients, whose strokes’ origins cannot be determined, are said to have had a cryptogenic stroke.

A small percentage of patients who have had a cryptogenic stroke are thought to be caused from a patent foramen ovale, providing a way for a clot to travel to the brain where it then blocks a blood vessel, causing a stroke.

These patients are at an increased risk of experiencing recurrent strokes, making prevention key. The Amplatzer PFO Occluder is implanted through a catheter in a leg vein, which is then advanced to the heart where it is implanted to close the hole between the right atrium and the left atrium, the FDA reported.

The device has been available, but it was under a humanitarian device exemption. The Amplatzer PFO Occluder was withdrawn in 2006 after the FDA discovered that this population was more than 4000 patients, meaning that it no longer qualified for humanitarian device exemption approval.

When the device was off the market, there have been no approved heart occlude devices specifically for patients with patent foramen ovale (PFO) to decrease the risk of recurrent strokes.

The FDA approval was based on safety and efficacy data from a study that included 499 patients 18- to 60-years-old who were all treated with the Amplatzer PFO Occluder along with blood thinners. The study also included 481 patients who were just treated with blood thinners.

The investigators found that the rate of recurring strokes was very low in both groups. However, patients who received the Amplatzer PFO Occluder plus blood thinners had a 50% reduction in new strokes compared with those only taking blood thinners.

Adverse effects included injury to the heart, atrial fibrillation, blood clots in the heart, leg, or lung, bleeding, and stroke, according to the FDA.

This device should not be used in patients with a heart valve infection or an infection of any kind, or those with a heart tumor or clot at implantation site. The device may also be used in patients with abnormal connections between the heart chamber, or those who have anatomical features that do not allow for the device to move through the leg to the heart.

Patients should discuss this treatment option with their cardiologist and neurologist compared with using medications, the FDA advised.

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