FDA Approves GORE CARDIOFORM Septal Occluder for Ischemic Stroke Prevention

The US Food and Drug Administration (FDA) has approved an expanded indication for the GORE CARDIOFORM Septal Occluder device, to include the closure of patient foramen ovale (PFO) to prevent recurrent ischemic stroke in certain patients.

The FDA’s decision was made based on the data from the REDUCE study, the first and only study to validate PFO closure’s ability to prevent recurrent ischemic stroke regardless of the anatomy of the PFO, according to WL Gore & Associates.

"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, from the Medical University of South Carolina, and U.S. Interventional Cardiologist National Principal Investigator for the REDUCE Study, said in a statement. "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."

REDUCE involved 664 patients, 81% of which had moderate or large interatrial shunts, dividing them into a PFO group (n = 441) to receive the device and a control group (n = 223). Ischemic stroke occurred in 1.4% (n = 6) of the PFO group compared to 5.4% (n = 12) in the control group (hazard ratio, 0.23; 95% CI, 0.09-0.62; P = .002).

Overall, after a 3.4-year period of follow-up, that equated to a 77% reduction in recurrent ischemic stroke in the patients who underwent PFO closure with the device coupled with antiplatelet therapy compared with those who utilized antiplatelet therapy alone.

Additionally, new stroke occurred at a much lower rate in the PFO group (5.7%; n = 22) than the control group (11.3%; n = 20; relative risk, 0.51; 95% CI, 0.29-0.91; P = .04). Silent brain infarction, however, was not significantly different between the 2 groups (P = .97)

"The groundbreaking results of the REDUCE Study changed the neurology community's perspective on PFO closure when they were announced," Scott Kasner, MD, a neurologist in the Perelman School of Medicine at the University of Pennsylvania, and U.S. Neurology National Principal Investigator for the REDUCE Study, said in a statement. "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."

The device is delivered via catheter and is comprised of 2 conformable discs that cover the defects in the heart’s anatomy utilizing Gore’s ePTFE film, which allows for “optimal apposition to surrounding anatomy and enables rapid tissue ingrowth for immediate closure and lasting long-term performance,” according to Gore.

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