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GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

INDICATIONS FOR USE UNDER CE MARK: The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion is indicated for use in the treatment of portal hypertension and its complications such as variceal bleeding and refractory ascites. TIPS: Transjugular Intrahepatic Portosystemic Shunt. CONTRAINDICATIONS: There are no known contraindications for this device. 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® INTERING® Vascular Graft

INDICATIONS FOR USE UNDER CE MARK: Gore Vascular Grafts are indicated for patients who require replacement or bypass of aortic or peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). CONTRAINDICATIONS: DO NOT use GORE-TEX® Vascular Grafts as a patch. If cut and used as a patch, GORE-TEX® Vascular Grafts may lack adequate transverse strength. For cardiovascular procedures requiring patch materials, use the appropriate GORE-TEX® Cardiovascular Patch. DO NOT use any of the below configurations for coronary artery bypass or cerebral reconstruction procedures: GORE-TEX® Vascular Graft FEP Ring; GORE-TEX® STRETCH Vascular Graft FEP Ring; GORE-TEX® Vascular Graft FEP Removable Ring; GORE-TEX® STRETCH Vascular Graft FEP Removable Ring; GORE® INTERING® Vascular Graft. 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

INDICATIONS FOR USE UNDER CE MARK: GORE® PROPATEN® Vascular Graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). 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. FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL 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

 

GORE-TEX® STRETCH Vascular Graft 

INDICATIONS FOR USE UNDER CE MARK: Gore Vascular Grafts are indicated for patients who require replacement or bypass of aortic or peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). CONTRAINDICATIONS: DO NOT use GORE-TEX® Vascular Grafts as a patch. If cut and used as a patch, GORE-TEX® Vascular Grafts may lack adequate transverse strength. For cardiovascular procedures requiring patch materials, use the appropriate GORE-TEX® Cardiovascular Patch. DO NOT use any of the below configurations for coronary artery bypass or cerebral reconstruction procedures: GORE-TEX® Vascular Graft FEP Ring; GORE-TEX® STRETCH Vascular Graft FEP Ring; GORE-TEX® Vascular Graft FEP Removable Ring; GORE-TEX® STRETCH Vascular Graft FEP Removable Ring; GORE® INTERING® Vascular Graft. 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® Vascular Graft 

INDICATIONS FOR USE UNDER CE MARK: Gore Vascular Grafts are indicated for patients who require replacement or bypass of aortic or peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). CONTRAINDICATIONS: DO NOT use GORE-TEX® Vascular Grafts as a patch. If cut and used as a patch, GORE-TEX® Vascular Grafts may lack adequate transverse strength. For cardiovascular procedures requiring patch materials, use the appropriate GORE-TEX® Cardiovascular Patch. DO NOT use any of the below configurations for coronary artery bypass or cerebral reconstruction procedures: GORE-TEX® Vascular Graft FEP Ring; GORE-TEX® STRETCH Vascular Graft FEP Ring; GORE-TEX® Vascular Graft FEP Removable Ring; GORE-TEX® STRETCH Vascular Graft FEP Removable Ring; GORE® INTERING® Vascular Graft. 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® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface 

INDICATIONS FOR USE UNDER CE MARK: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of: de novo or restenotic lesions in the iliac arteries; de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery; in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery; stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins; popliteal artery aneurysms and isolated visceral artery aneurysms; traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries). CONTRAINDICATIONS: Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation or where lesions cannot be dilated sufficiently to allow passage of the delivery system. DO NOT use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 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® VIABAHN® VBX Balloon Expandable Endoprosthesis 

INDICATIONS FOR USE UNDER CE MARK: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of: de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; de novo or restenotic lesions in the visceral arteries; isolated visceral, iliac, and subclavian artery aneurysms; or traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral and pulmonary arteries). CONTRAINDICATIONS: DO NOT use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT (Heparin-Induced Thrombocytopenia) type II. 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 TIPS Set – GORE® TIPS Sheath and GORE TIPS Needle

INDICATIONS FOR USE UNDER CE MARK: The GORE TIPS Set, GORE® TIPS Sheath and GORE TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. CONTRAINDICATIONS: There are no known contraindications for these devices. 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® ACUSEAL Vascular Graft

INDICATIONS FOR USE UNDER CE MARK: GORE® ACUSEAL Vascular Graft is indicated for patients who require arteriovenous hemodialysis access in the upper or lower extremities for End Stage Renal Disease (ESRD). CONTRAINDICATIONS: DO NOT use the GORE® ACUSEAL Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. DO NOT use GORE® ACUSEAL Vascular Graft as a patch. If cut and used as a patch, GORE® ACUSEAL Vascular Graft may lack adequate transverse strength. FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL 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

 

GORE-TEX® Suture

INDICATIONS FOR USE UNDER CE MARK: The GORE-TEX® Suture is indicated for use in surgical procedures where general soft tissue approximation and/or ligation is required including cardiovascular surgery, repair of mitral valves, and the replacement of chordae tendineae. CONTRAINDICATIONS: No known contraindications. 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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