FDA Approves Patent Foramen Ovale Occluder for Prevention of Recurrent Stroke
Careful evaluation is required to rule out any other known causes of stroke in patients with PFO.
The US Food and Drug Administration (FDA) has approved a device that reduces the risk of recurrent stroke in patients with patent foramen ovale (PFO).
The device, the AmplatzerTM PFO Occluder, provides a non-surgical method of PFO closure for the approximately 25 to 30% of Americans with a PFO who may be at increased risk for cryptogenic stroke, and is the first FDA-approved heart occluder device to be available to this specific population in 10 years.
The device is inserted through a catheter in a leg vein. Once at the heart, the device is implanted near the PFO between the right and left atrium. “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,” noted Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health.
The device's safety and efficacy was established in a randomized trial of 499 patients aged 18 to 60 years treated with the PFO occluder device plus anticoagulants compared with 481 patients treated with anticoagulants alone. Participants with the occluder device plus anticoagulants showed a 50% reduction in re-occurring strokes, compared to the group who only received treatment with anticoagulants. Adverse effects include injury to the heart from implantation, atrial fibrillation, thrombosis in the heart, leg, or lung, bleeding, and stroke.
The device is not indicated for patients with heart valve infection, other untreated infections, heart tumors, or blood clots at the implant site. Patients with other abnormal cardiovascular anatomy features should not use this device.
FDA approves new device for prevention of recurrent strokes in certain patients [news release]. FDA Newsroom. Published October 28, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm. Accessed November 2, 2016.