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GORE® CARDIOFORM Septal Occluder

INTENDED USE UNDER CE MARK: The GORE® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of atrial septal defects (ASDs), such as ostium secundum and patent foramen ovale. 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. RXOnly

GORE® CARDIOFORM ASD Occluder

INTENDED USE UNDER CE MARK: The GORE® CARDIOFORM ASD Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). CONTRAINDICATIONS: The GORE® CARDIOFORM ASD Occluder is contraindicated for use in patients: unable to take anti-platelet or anticoagulant medications such as aspirin, heparin or warfarin; with anatomy where the GORE® CARDIOFORM 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. RXOnly

GORE® PROPATEN® Vascular Graft configured for Pediatric Shunt

INTENDED USE UNDER CE MARK: GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt is indicated for staged palliative repair of cyanotic congenital heart disease (CCHD). CONTRAINDICATIONS: DO NOT use the GORE® PROPATEN® Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II. DO NOT use any of the below configurations of GORE® PROPATEN® Vascular Graft for coronary artery bypass or cerebral reconstruction procedures: GORE® PROPATEN® Vascular Graft Integrated Rings. GORE® PROPATEN® Vascular Graft Fixed Ring. GORE® PROPATEN® Vascular Graft Removable Ring. GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral. DO NOT use GORE® PROPATEN® Vascular Graft as a patch. If cut and used as a patch, GORE® PROPATEN® Vascular Graft may lack adequate transverse strength. 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

GORE® PRECLUDE® Pericardial Membrane

INTENDED USE UNDER CE MARK: Reconstruction or repair of the pericardium. CONTRAINDICATIONS: Not for reconstruction of: cardiovascular defects, such as cardiac, great vessel and peripheral vascular; dura mater; hernias. Use of this product in applications other than those indicated has the potential for serious complications, such as suture pullout or failure of the repair (aneurysm formation). 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

GORE-TEX® Cardiovascular Patch

INTENDED USE UNDER CE MARK: The GORE-TEX® Cardiovascular Patch is indicated for use as a surgical patch in the treatment of carotid artery stenosis and the following congenital heart defects: ventricular septal defects; atrial septal defects; atrioventricular septal defects; complete atrioventricular canal defects; tetralogy of Fallot; coarctation of the aorta; double outlet right ventricle. CONTRAINDICATIONS: There are no known contraindications for the GORE-TEX® Cardiovascular Patch. 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

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