Join us in celebrating a major milestone

10th Anniversary GORE® CARDIOFORM Spectal Occluder

CELEBRATING A DECADE OF CLINICAL USE AND THE PEOPLE WHO MADE IT POSSIBLE

Thank you to all the healthcare professionals who chose the GORE^® CARDIOFORM Septal Occluder and helped achieve reliable safety results over 10 years of clinical use. We are proud to celebrate this milestone with you.

Used globally and backed by the Gore REDUCE Clinical Trial.*

W. L. Gore & Associates, Inc.
P.O. Box 2400, Flagstaff, AZ 86003-2400
USA
goremedical.com

The Gore REDUCE Study determined safety and efficacy of PFO closure with the GORE^® CARDIOFORM Septal Occluder or GORE^® HELEX^® Septal Occluder plus antiplatelet medical management compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke. All PFO anatomies were incorporated into this study within indicated sizing parameters of the Instructions for Use.

† W. L. Gore & Associates, Inc. GORE^® CARDIOFORM Septal Occluder Complete Bibliography. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2020. [Bibliography].

‡ Data on file. July, 2011-November, 2021; W. L. Gore & Associates, Inc.; Flagstaff, AZ.

1. Søndergaard L, Kasner SE, Rhodes JF, et al; Gore REDUCE Study Investigators. PFO closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2017;377(11):1033-1042.

2. Kasner SE, Rhodes JF, Andersen G; Gore REDUCE Clinical Study Investigators. Five-year outcomes of PFO closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2021;384(10):970-971.

INDICATIONS FOR USE IN THE U.S.: The GORE^® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: ostium secundum atrial septal defects (ASDs); patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. CONTRAINDICATIONS: The GORE^® CARDIOFORM Septal Occluder is contraindicated for use in patients: unable to take antiplatelet or anticoagulant medications such as aspirin, heparin or warfarin; with anatomy where the GORE^® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins; with active endocarditis, or other infections producing bacteremia, or patients with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement; with known intracardiac thrombi. 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.

Products listed may not be available in all markets.

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