FDA approves septal occluder for PFO closure to prevent recurrent ischaemic stroke

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The REDUCE clinical study demonstrated a 77% relative reduction in recurrent ischaemic stroke when patent foramen ovale (PFO) closure was combined with antiplatelet therapy, compared to antiplatelet therapy alone.

Following the REDUCE clinical study conclusion that closure of patent foramen ovale can prevent recurrent ischaemic strokes, Gore has received approval from the US Food and Drug Administration (FDA) for an expanded indication for its GORE CARDIOFORM Septal Occluder. The device is now also approved for the closure of PFO to reduce the risk of recurrent ischaemic stroke in certain patients.

“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, Medical University of South Carolina, and US 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 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 ischaemic 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 ischaemic strokes, regardless of PFO anatomy. The results were published in the New England Journal of Medicine in September 2017and presented at the European Stroke Organisation Conference 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, Neurologist in the Perelman School of Medicine at the University of Pennsylvania, and US Neurology National Principal Investigator for the REDUCE Study. “The REDUCE Study was the first US 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”

The REDUCE Study is the only PFO US IDE study to meet its primary endpoint in the primary intent-to-treat analysis. Results showed a statistically significant, 77%, reduction in recurrent ischaemic 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.

 

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