St. Jude Medical’s stroke-fighting heart occluder picked up FDA approval on Friday. The device had previously been available in the U.S. under a humanitarian device exemption, but was voluntarily recalled by St. Jude in 2006 when it no longer qualified for the exemption.
The Amplatzer PFO Occluder reduces the risk of stroke in patients who have previously suffered a stroke believed to stem from a blood clot that made its way to the brain after passing through a hole in the heart called a patent foramen ovale (PFO). It is delivered through the leg in a minimally invasive procedure and implanted close to the hole between the right and left atria.
“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, in an FDA 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.”
While approximately 25% to 30% of Americans have a PFO, the hole generally doesn’t cause any health issues, according to the FDA. But it might play a role in some patients who have suffered cryptogenic strokes, or strokes that do not have any identifiable cause. In a small subgroup of these patients, it is believed that a PFO may have allowed a blood clot a route to the brain, according to the statement. These patients may be at greater risk of a second stroke.
While the device had been on the market under an HDE until 2006, the FDA did not approve any other heart occluder for the prevention of strokes in patients that have a PFO and have experienced a previous stroke. The new approval is based on a randomized study involving 980 patients aged 18 to 60. About half of the patients were treated with blood thinners and the Amplatzer device, while the other half received blood thinners alone. Both groups reported low rates of new strokes, but the patients who received the Amplatzer and blood thinners had a 50% lower rate than those in the other group.