FDA officials approved the new device for select patients after conducting a randomized safety study. Photo by Intel Free Press/Flickr
WASHINGTON, Oct. 31 (UPI) -- The U.S. Food and Drug Administration has approved the Amplatzer PFO Occluder device for select patients to reduce their risk of recurrent strokes.
The PFO Occluder is a tool designed for patients who have previously experienced a stroke as a result of a blood clot passing through a small hole in the heart called the patent foramen ovale, or PFO. While its use can improve treatment for many patients, it's not for everyone.
"The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO," FDA Division of Cardiovascular Devices director Bram Zuckerman 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."
PFOs are found in approximately 25 to 30 percent of Americans, and normally do not cause any health problems. For some stroke patients a cause cannot be identified, and it is believed that in a small percentage of these patients, the PFO can become a pathway for a blood clot to travel to the brain and block a blood vessel, causing a stroke.
The Amplatzer PFO Occluder is inserted through a catheter placed in a leg vein, eventually traveling to the heart and implanting close to the hole between the right and left atriums.
FDA officials say this approach can drastically reduce the risk of a second stroke, based on the results of a randomized safety study. During the research, 499 participants were treated with the occluder in addition to blood-thinning medications, while an additional 481 patients only received the medications. Investigators noted a 50 percent drop in the rate of new strokes in the experimental group.
Despite the positive results observed in the experiment, the FDA warns the Amplatzer Occluder may have adverse effects incuding heart injury, irregular heart rates, blood clots, bleeding and strokes. Officials advise patients interested in using the device to consult neurologists and cardiologists to assess the risks.