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<p>FDA approves new non-surgical technology designed to correct condition that can cause repeat events.</p>

Device Could Prevent Recurrent Strokes for Select Patients

November 1, 2016

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By Jonathan Springston, Assistant Editor, AHC Media

The FDA this week approved the Amplatzer PFO Occluder, a device manufacturers say provides a non-surgical option for reducing the risk of repeat strokes in certain patients.

About one-quarter of Americans have a patent foramen ovale (PFO), a small hole in the heart researchers believe serves as a gateway through which stroke-causing blood clots can travel. Often, PFOs are harmless and require no treatment. Further, clinicians can trace strokes to common medical maladies such as atrial fibrillation, uncontrolled high blood pressure, and atherosclerosis. However, some patients suffer cryptogenic strokes, whereby clinicians cannot definitively determine the cause. It is in a few of these cases clinicians believe a blood clot used a PFO to travel to the brain, causing the stroke. Most importantly, it is these patients who are at risk for a second stroke.

Medical staff implant the Occluder through a catheter placed in a leg vein and advance it to the heart. The device remains close to the hole between the right and left atriums. The FDA assessed the device’s safety in a randomized trial that evaluated 499 participants 18-60 years of age who were treated with the Occluder plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications only. Researchers discovered a 50% reduction in the rate of new strokes in participants using the Occluder plus blood-thinning medications compared to participants taking only medication.

“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.”

For all the latest news and commentary of cardiology and neurology, be sure to read Clinical Cardiology Alert and Neurology Alert.