The Latest Cardiac and Vascular News
– Published in the New England Journal of Medicine (NEJM), the REDUCE Study continues to show the largest reduction in recurrent ischemic stroke in all PFO shunt sizes over medical therapy alone.*,¹ – Long-term results highlight GORE® CARDIOFORM Septal Occluder can be trusted for patient safety and effective defect closure. FLAGSTAFF, Ariz., March 11, 2021 /PRNewswire/ — W. L. Gore […]
FLAGSTAFF, Ariz., June 4, 2019 /PRNewswire/ — W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study which demonstrated […]
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE®CARDIOFORM ASD Occluder is designed […]
FLAGSTAFF, Ariz., April 3, 2018 /PRNewswire/ — 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 U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already approved for closure of atrial […]
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE® CARDIOFORM ASD Occluder is designed […]
