W. L. Gore & Associates, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for expanded use for the Gore Cardioform Septal Occluder.
The device, already approved for closure of atrial septal defects under a certain size is now also approved for the closure of PFO to reduce the risk of a type of stroke.
Most people with a PFO — a hole occurring in the upper wall between the left and right atria (cavities) of the heart — do not experience any issues when blood flows from one atrium to the other; however, serious problems such as stroke can arise if a blood clot passes from the right to left atria through a PFO and then to the brain.
The expanded FDA indication was supported by the Reduce Study.
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.
“With the FDA approval of the 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,” said David Abeyta, leader of the Gore Medical Products Division. “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 catheter-delivered the Gore Cardioform Septal Occluder leverages Gore’s more than 15 years of experience in endovascular structural heart devices and more than 35,000 occluder implants worldwide. It is made up of two independent conformable discs that span and cover the heart’s anatomy to close defects. Gore’s ePTFE film covers a minimal wireframe.
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. More than 40 million medical devices have been implanted over the course of more than 40 years.
Gore Medical Products is headquartered in Flagstaff, AZ. W.L. Gore is headquartered in Newark.