Medical Device for Stroke Prevention Approved By FDA

The US Food and Drug Administration (FDA) has approved a medical device – called the Amplatzer PFO Occluder – for the prevention of recurrent strokes in select patients. The device is designed for patients who have previously experienced a stroke thought to be due to a patent foramen ovale (PFO). The PFO is a small hole in the heart which could allow a blood clot to pass through on its way to the brain.

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

It’s estimated that up to 30 percent of Americans have a PFO, which is completely benign in most people. While the trigger for many strokes can be established – including high blood pressure, cholesterol deposits in blood vessels or atherosclerosis – the cause of some strokes is unknown.

Physicians refer to this type of stroke as cryptogenic, and in some of these patients it’s believed that the PFO could have allowed a blood clot to travel to the brain and cause a stroke. Patient outcomes data suggest that those who have a PFO and who have also suffered a cryptogenic stroke, might be more likely to experience subsequent strokes in the future.

The Amplatzer PFO Occluder is implanted close to the PFO in the heart in an effort to close the gap. While the device was previously marketed under the humanitarian device exemption, it was voluntarily pulled from the market by the manufacturer in 2006 after it no longer qualified for the exemption.

Now, the device has been approved by the FDA based on safety and efficacy data assessed in a clinical trial. The randomized trial included 499 participants who were treated with the medical device along with blood thinners, and 481 participants who were given the blood thinners on their own.

The organizers of the clinical trial found that patients treated with the medical device and the blood thinners faced a 50 percent lower risk of recurrent stroke, compared to those on the blood thinners alone. The Amplatzer PFO Occluder medical device is manufactured by St. Jude Medical Inc.