FDA Approves the Gore Cardioform Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke
April 3, 2018—Gore & Associates announced that it has received approval from the US Food and Drug Administration (FDA) for an expanded indication of its Gore Cardioform septal occluder for the closure of patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in certain patients. The device has previously been approved for closure of atrial septal defects (ASDs) up to 17 mm.
FDA approval of the expanded indication was supported by the REDUCE clinical study, which concluded that PFO closure can prevent recurrent ischemic strokes.
In September 2017, the REDUCE results were published by Lars Søndergaard, MD, et al in The New England Journal of Medicine (2017;377:1033–1042). The data were presented in May 2017 at the European Stroke Organization Conference in Prague, the Czech Republic.
According to the company, the REDUCE study, which was conducted under a United States investigational device exemption (IDE), met its primary endpoint in the primary intent-to-treat analysis. Results showed a statistically significant 77% reduction in recurrent ischemic stroke in patients who underwent PFO closure with a Gore device in conjunction with antiplatelet therapy versus those who underwent antiplatelet therapy alone, after an average of 3.4 years of follow-up. The study also met its other primary endpoint of reduction of new brain infarct, inclusive of clinically evident and clinically silent brain infarct, through PFO closure, yielding a 49% relative risk reduction.
John Rhodes, MD, with Medical University of South Carolina in Charleston, South Carolina, served as United States Interventional Cardiologist National Principal Investigator for the REDUCE study.
In the company's announcement, Dr. Rhodes commented, "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. 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.”
Scott Kasner, MD, the United States Neurology National Principal Investigator for the REDUCE study, added, “The groundbreaking results of the REDUCE study changed the neurology community’s perspective on PFO closure when they were announced. The REDUCE study was the first United States 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.” Dr. Kasner is a neurologist with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania.