FDA approves GORE CARDIOFORM Septal Occluder to prevent recurrent ischaemic strokes.- W. L. Gore & Associates, Inc.

Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the FDA for an expanded indication for its GORE CARDIOFORM Septal Occluder.

The device, already approved for closure of atrial septal defects (ASDs) up to 17 mm, 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 ischemic 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.