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PFO closure device now approved for recurrent ischemic stroke prevention
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W.L. Gore and Associates announced the FDA has granted a new indication for prevention of recurrent ischemic stroke for its patent foramen ovale closure device.
The expanded approval of the device (Gore Cardioform Septal Occluder) was supported by the results of the REDUCE study, which showed that PFO closure significantly reduced the rate of recurrent ischemic stroke, according to a press release issued by the company.
According to Scott Kasner, MD, neurologist in the Perelman School of Medicine at the University of Pennsylvania, the results of the REDUCE study changed the neurology community’s perspective on PFO closure.
“The REDUCE Study was the first U.S. Investigational Device Exemption (IDE) study to show a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis,” he said in a press release. “It was also the first study to show PFO closure reduces new brain infarct. I am excited that the Gore Cardioform Septal Occluder is now FDA-approved for PFO closure and believe these data prove the value of closing PFOs to prevent recurrent ischemic stroke when utilized in an appropriate patient population.”
The REDUCE study showed 77% reduction in recurrent ischemic stroke in patients who underwent PFO closure with the device combined with antiplatelet therapy compared with patients who had antiplatelet therapy alone.
“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, interventional cardiologist at Medical University of South Carolina and national principal investigator of REDUCE, said in the release. “The clear reduction in recurrent ischemic stroke provided by PFO closure far outweighs the low risk of serious adverse events.”
Disclosures: The REDUCE trial was funded by W.L. Gore and Associates. Kasner reports he received a research grant from W.L. Gore and Associates. Rhodes reports he has served as a consultant and speaker for W.L. Gore and Associates and served as national principal investigator of REDUCE.