The US Food and Drug Administration (FDA) has approved the Gore Cardioform septal occluder for closure of patent foramen ovale (PFO) to prevent recurrent ischemic stroke, the manufacturer, WL Gore & Associates Inc, has announced.
The device is already approved for closure of atrial septal defects (ASDs) up to 17 mm.
FDA approval of the Gore Cardioform septal occluder for PFO closure was based on results of the Gore-REDUCE clinical trial, in which 664 patients from seven countries were randomly assigned to PFO closure with the Gore Helex (implanted through late 2012) or the Gore Cardioform (implanted from late 2012 onward) septal occluder or to antiplatelet therapy alone.
Results showed a statistically significant 77% relative reduction in recurrent ischemic stroke in patients who underwent PFO closure with a Gore device in conjunction with antiplatelet therapy vs those who received antiplatelet therapy alone, after an average of 3.4 years of follow-up. At 2 years, the number needed to treat with the device to prevent one new stroke was 28.
The REDUCE trial also showed a 49% relative reduction in new brain infarction on MRI.
The results were presented at the 3rd European Stroke Organisation Conference in May 2017, published in the New England Journal of Medicine in September 2017 () and reported by Medscape Medical News at that time.
PFO, an opening between the left and right atria, is relatively common in the general population but is even more common among patients who have had a cryptogenic ischemic stroke, that is, a stroke of unknown cause. The clinical benefit of closing a PFO after cryptogenic stroke has been debated for years.
The FDA approval of the Gore Cardioform septal occluder for PFO closure “marks a significant milestone in the long journey to confirm the heart-brain relationship connecting PFO and stroke,” John Rhodes, MD, from the Medical University of South Carolina, Charleston, and US interventional cardiologist national principal investigator for the REDUCE study, said in a news release from WL Gore announcing approval.
“The soft and conformable design of Gore’s device is ideal for providing long-term repair of PFOs of any shunt size,” said Rhodes.
He was also impressed, he said, with the rate of serious adverse events in the REDUCE study, which showed no significant difference in risk between closure and medical therapy alone. “The clear reduction in recurrent ischemic stroke provided by PFO closure far outweighs the low risk of serious adverse events,” added Rhodes.
Scott Kasner, MD, neurologist at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and US neurology national principal investigator for the REDUCE study, said the “groundbreaking results of the REDUCE study changed the neurology community’s perspective on PFO closure when they were announced.”
Kasner also noted in the release that REDUCE was the first US Investigational Device Exemption study to show a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis and the first to show that PFO closure reduces new brain infarct.
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