FLAGSTAFF, Ariz., April 3, 2018 /PRNewswire/ -- Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already approved for closure of atrial septal defects (ASDs) up to 17 mm, is now also approved for the closure of PFO to reduce the risk of recurrent ischemic stroke in certain patients.*
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"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," said John Rhodes, MD, Medical University of South Carolina, and U.S. Interventional Cardiologist National Principal Investigator for the REDUCE Study. "The soft and conformable design of Gore's device is ideal for providing long-term repair of PFOs of any shunt size. I am pleased that a device I have grown to trust for ASD closure is now FDA approved for PFO closure as well. I am also impressed 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."
The expanded FDA indication was supported by the REDUCE Study, the first and only study to demonstrate that closure of PFO can significantly prevent recurrent ischemic strokes, regardless of PFO anatomy. The results were published in the New England Journal of Medicine in September 2017 and presented at the European Stroke Organisation Conference (ESOC) last May.
"The groundbreaking results of the REDUCE Study changed the neurology community's perspective on PFO closure when they were announced," said Scott Kasner, MD, Neurologist in the Perelman School of Medicine at the University of Pennsylvania, and U.S. Neurology National Principal Investigator for the REDUCE Study. "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. 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."