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* Reported incidence rate of device-related cardiac erosions for GORE® CARDIOFORM ASD Occluder calculated using data from CATSWeb® Product Surveillance Tracking System [PSTS] and Smartsolve.® Data on file. March 1, 2015 – July, 31,2024; W. L. Gore & Associates Inc.; Flagstaff, AZ. 

  1. Sommer RJ, Love BA, Paolillo JA, et al.; ASSURED Investigators. ASSURED clinical study: new GORE® CARDIOFORM ASD Occluder for transcatheter closure of atrial septal defect. Catheterization & Cardiovascular Interventions 2020;95(7):1285-1295.

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Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

CATSWeb is a trademark of AssurX, Inc. 
SMARTSOLVE is a trademark of Ethos Technologies Inc.

24CR2024-EN01