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FDA approves PFO occlusion device for reduction of recurrent stroke risk
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St. Jude Medical announced the FDA approved its transcatheter device for occlusion of patent foramen ovale.
The device (Amplatzer PFO Occluder) is the first approved by the agency for PFO closure for prevention of recurrent stroke in patients with a PFO and cryptogenic stroke, according to a press release issued by the company.
“This is a well-studied therapy with a strong safety profile,” Jeffrey L. Saver, MD, director of the stroke center at UCLA and professor of neurology at David Geffen School of Medicine, said in the release. “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.”
According to the release, a correlation between the presence of PFO and the risk for ischemic stroke had been suspected for some time, and nearly half of patients with cryptogenic stroke have a PFO.
The approval was based on 8 years of data from the RESPECT trial, in which use of the device was associated with a more than 50% reduced risk for recurrent stroke compared with medical management in nearly 1,000 patients with a PFO and cryptogenic stroke, according to the release.
In May, an FDA advisory panel voted to approve the device, with a majority concluding it was safe and effective and its benefits outweighed its risks.
“Interventional cardiology and vascular neurology in major U.S. and Canadian medical centers have worked together for over a decade to develop the scientific proof from this randomized trial that PFO closure substantially reduces the risk of recurrent stroke in these otherwise healthy patients,” John D. Carroll, MD, director of interventional cardiology and the Cardiac and Vascular Center at the University of Colorado Hospital, said in the release. “The Amplatzer PFO Occluder procedure takes less than 1 hour to complete, can be performed with conscious sedation and subsequently provides these patients with over a 50% reduction of risk for having another stroke for many years to come.”