– 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 […]
Tag: Cardioform
GORE® CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects
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 […]
Gore Completes Patient Enrollment in U.S. Pivotal Clinical Study of GORE® CARDIOFORM ASD Occluder
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 […]
FDA Approves GORE® CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke
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 […]
W. L. Gore & Associates Completes Patient Enrollment In U.S. Pivotal Clinical Study Of GORE CARDIOFORM ASD Occluder
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 […]