Preventive Stroke Device Gets FDA Approval

People who have had a stroke before are more likely to have another. On October 28, the US Food and Drug Administration (FDA) approved the Amplatzer PFO Occluder, a device indicated to lower that risk.

The device is manufactured by St. Jude Medical Inc. based in Minnesota. It offers a non-surgical option for patients who previously had a stroke caused by a blood clot passing through a patent foramen ovale (PFO), a small hole in the heart, which then made its way to the brain. The device is placed in a leg vein and advanced to the heart where it is implanted between the top right chamber and the top left chamber (otherwise known as the right atrium and left atrium).

PFOs usually do not cause health problems or require treatment. In fact, around 25% to 30% of the population in the United States have a PFO. When tests are unable to determine what caused a stroke, it’s called a cryptogenic stroke. For those who have this type of stroke as well as a PFO may have a higher risk of a second stroke — and these are the patients that the Occluder is meant for.

Using nearly 1,000 participants ages 18 to 60, researchers were able to confirm the device’s safety and efficacy. A total of 499 patients were treated with the Amplatzer PFO Occluder and blood-thinning medications. Their results were compared to 481 patients who only received blood-thinning medications. Both groups had very low rates of new strokes, but the group that also received the Occluder device had a 50% reduction in new strokes.

“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,” Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA’s Center from Devices and Radiological Health, said in a news release.

Adverse effects with the Occluder included: stroke, bleeding, injury to the heart, irregular heart rate, rapid heart rate (atrial fibrillation), blood clots in the heart, leg, or lung. The FDA says that it should not be used in patients with a heart tumor, blood clot at the implant site, heart valve infection or other untreated infections.

Over 10 years ago, this device was on the market under a humanitarian device (HDE). However, the FDA determined that the target population was more than 4,000 patients so it no longer qualified under the HDE approval. The manufacturer voluntarily took it off of the market in 2006. Since then, there has not been a device specifically designed to close PFOs in order to reduce recurrent stroke risk in those with cryptogenic stroke history.

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