The US Food and Drug Administration (FDA) has approved the Amplatzer PFO [patent foramen ovale] Occluder device (St Jude Medical Inc) to reduce the risk for recurrent stroke, the agency announced in a statement released today.
The device will be indicated for patients who had a previous stroke thought to be caused by a PFO.
The occluder "provides a non-surgical method for doctors to close a PFO," Bram Zuckerman, MD, director of the Division of Cardiovascular Devices at the Center for Devices and Radiological Health at the FDA, said in the release.
He pointed out, though, that labeling will emphasize the need for patients to first be carefully evaluated by both a neurologist and a cardiologist to make sure there weren't other causes for the stroke.
The agency notes that approximately 25% to 30% of individuals in the United States have a PFO, often unknowingly because it doesn't usually cause any health problems.
However, the PFO can provide a pathway to the brain for blood clots in certain patients. And "patients with a cryptogenic stroke and a PFO may be at an increased risk of having a second stroke," the FDA notes.
Interestingly, the Amplatzer occluder first became available 10 years ago under a humanitarian device exemption before being withdrawn in 2006. At that point the FDA concluded that the device no longer qualified for that type of approval because the target population had grown to more than 4000 patients.
Based on RESPECT
The FDA based their new approval on results from the randomized RESPECT trial. As reported by heartwire from Medscape, 10-year data were presented at last year's Transcatheter Cardiovascular Therapeutics (TCT) meeting.
The 980-person trial showed that although the rates of stroke were low in both the treatment and control groups, those who underwent PFO closure with the occluder device had a 54% relative risk reduction for recurrent cryptogenic stroke compared with those assigned to medical management/anticoagulants.
At a late-breaking clinical trial session at the TCT meeting, moderator Martin B. Leon, MD, New York-Presbyterian Hospital, Columbia University Medical Center, New York City, said at the time that "most of us believe that there is a core of meaningful therapy here that needs to find its way to regulatory expression."
But in May of this year, an FDA advisory panel gave only a "tepid nod" to the device for cryptogenic stroke. Fifteen of the 16 members voted that it was safe, but only 9 agreed that it was effective. Only 11 members agreed that it had "greater benefits than risks."
Today's approval is "an important step for patients living in fear of recurrent stroke as a result of a PFO, and offers physicians more options to help their patients make decisions that best fit their lives," Mark D. Carlson, MD, chief medical officer at St Jude Medical, said in the company's own release.
RESPECT investigator John D. Carroll, MD, University of Colorado School of Medicine, Aurora, said in the same release that many people in the United States and Canada worked together for many years "to develop the scientific proof" about this device.
The occlusion procedure "takes less than one hour to complete [and] can be performed with conscious sedation," Dr Carroll added.
"This is a well-studied therapy with a strong safety profile," said Jeffrey L. Saver, MD, director of the stroke center at the University of California, Los Angeles, and professor of neurology at David Geffen School of Medicine, is quoted also in the St Jude statement. "Given what we know about the devastating effects of ischemic stroke, the Amplatzer PFO Occluder is a compelling treatment option in preventing another stroke for patients with a history of cryptogenic stroke and a PFO who are otherwise young and healthy."
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Cite this: FDA Approves Amplatzer PFO Occluder for Recurrent Stroke Prevention - Medscape - Oct 28, 2016.