FDA approves septal occluder for PFO closure to prevent recurrent stroke

Already approved for the purpose its name implies, the Gore Cardioform septal occluder has also received the FDA’s OK for patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke.

The device was previously approved for closing atrial septal defects (ASDs) up to 17 millimeters, W.L. Gore & Associates noted in its April 3 press release.

“With the FDA approval of the Gore Cardioform Septal Occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs,” David Abeyta, leader of the Gore medical products division, said in the release. “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.”

REDUCE, which was published online in the New England Journal of Medicine in September, demonstrated a 77 percent reduction in recurrent ischemic strokes in patients who underwent PFO closure with the device versus those who didn’t. Individuals in both groups received antiplatelet therapy. The risk of new brain infarcts was also cut by 49 percent in those receiving PFO closure compared to those treated with antiplatelets alone.

The device includes two independent, adaptable discs that can cover areas of the heart and close defects.

“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, an interventional cardiologist at the Medical University of South Carolina and the national principal investigator of REDUCE.

“The soft and conformable design of Gore’s device is ideal for providing long-term repair of PFOs of any shunt size. … 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.”