FDA Approved Septal Occluder for PFO Closure to Prevent Ischemic Stroke

Image Credit : cardiovascularbusiness

The Gore Cardioform septal occluder received the FDA approval for patent foramen ovale (PFO) closure to prevent recurrent ischemic attacks

The device comprises two independent and adaptable discs that cover areas of the heart to close defects. According to the press release of April 3, 2018, the device was previously approved for closing atrial septal defects (ASDs) up to 17 millimeters noted W.L. Gore & Associates. “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.”

The study published online in the New England Journal of Medicine in September 2017, demonstrated a 77% reduction in recurrent ischemic strokes in patients undergoing PFO closure with the device as compared to those who didn’t. Individuals in both groups received antiplatelet therapy. The risk of new brain infarcts was also cut by 49% in those receiving PFO closure compared to those treated with antiplatelets alone. “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.

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