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

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Following the results of the Gore REDUCE clinical study, which found that closure of patent foramen ovale (PFO) can prevent recurrent ischaemic strokes, Gore has received approval from the US FDA for an expanded indication for its Cardioform Septal Occluder. The device, already approved for closure of atrial septal defects (ASDs) up to 17mm, is now also approved for the closure of PFO to reduce the risk of recurrent ischemic stroke in certain patients.

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 2017 and presented at the European Stroke Organisation Conference (ESOC) last May.

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, vs. 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, Medical University of South Carolina, USA, and national principal investigator for the REDUCE study says: “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.”

David Abeyta, leader of the Gore Medical Products Division, says: “With the FDA approval of the Cardioform Septal Occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The value of closing PFOs has historically been debated, mainly due to a lack of sufficient data. We are enthusiastic that our positive REDUCE Study results allowed us to obtain an expanded FDA indication for this device and strongly believe the data show this is a prevention strategy for reducing the risk of recurrent ischemic stroke in patients with a PFO.”

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