The FDA approved the Amplatzer PFO Occluder device to reduce stroke risk for patients with prior cryptogenic stroke believed to be caused by a patent foramen ovale (PFO)-related blood clot.
The move marks a return to market after being withdrawn in 2006, when the FDA determined it no longer qualified for a humanitarian device exemption as the target population for this device was greater than 4,000 patients. "For the past 10 years, no FDA-approved heart occluder devices have been on the market specifically indicated to close PFOs to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke," the noted.
The panel advising the FDA on the Amplatzer device in May had voted overwhelmingly in favor of its safety, although adverse effects can include injury to the heart; atrial fibrillation; blood clots in the heart, leg, or lung; bleeding; and stroke.
But the panel was fairly split on efficacy (9-7 vote), citing problems with the RESPECT trial, which was the basis for approval but had failed to find superiority of the device over medical management alone for prevention of recurrent cryptogenic strokes. Subsequent analyses, however, showed fewer PFO-related second strokes.
Earlier this year, the American Academy of Neurology recommended against routine PFO closure for cryptogenic ischemic strokes.
"The Amplatzer PFO Occluder provides a nonsurgical method for doctors to close a PFO," Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said in a press release. "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."
The Amplatzer device is contraindicated for patients with a heart valve infection or other untreated infections, a heart tumor or blood clot at the implant site, other abnormal connections between the heart chambers, or if cardiovascular anatomy or blood clots would interfere with catheter mobility.