The FDA approved the Amplatzer PFO Occluder device Oct. 28 to help reduce the risk of recurrent ischemic strokes in patients with patent forance ovale (PFO).
St. Jude Medical, the device’s manufacturer, had studied the PFO Occluder for more than a decade. In May, an FDA advisory panel voted that the benefits of the Amplatzer PFO Occluder outweighed its risks.
Patients with a heart valve infection or other untreated infections or a heart tumor or blood clot at the implant site should not use the PFO Occluder, according to the FDA. The agency said approximately 25 percent to 30 percent of people in the U.S. have a PFO, which usually poses no health problems and does not require treatment. However, patients with a cryptogenic stroke and a PFO could have an increased risk of recurrent stroke.
The approval was based on results of the RESPECT trial, which enrolled 980 patients with PFO and cryptogenic stroke from August 2003 through December 2011. Results of the study were published in the New England Journal of Medicine in March 2013.
During the study, the researchers randomized patients in a 1:1 ratio to medical therapy alone or to the PFO Occluder device. Nine patients in the closure group and 16 in the medical therapy group had a recurrence of stroke. In addition, patients who used the PFO Occluder and blood thinners had a 50 percent reduction in the rate of new strokes compared with patients who only received blood thinners. Further, serious adverse events occurred in 23.0 percent of patients in the PFO Occluder group and 21.6 percent of patients in the medical therapy group.
The PFO Occluder was on the market under a humanitarian device exemption (HDE) more than a decade ago. AGA Medical, which developed the PFO Occluder, voluntarily recalled the device in 2006 after the FDA concluded the target population for the device was more than 4,000 patients. St. Jude Medical acquired AGA Medical in November 2010.
“The Amplatzer PFO Occluder provides a non-surgical 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 news 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.”