eIFU Symbol

GORE® DRYSEAL Flex Introducer Sheath

INTENDED USE UNDER CE MARK: The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions. 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® EXCLUDER® AAA Endoprosthesis

INDICATIONS FOR USE UNDER CE MARK: The GORE® EXCLUDER® AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: adequate iliac/femoral access; infrarenal aortic neck treatment diameter range of 19–32 mm and a minimum aortic neck length of 15 mm; proximal aortic neck angulation ≤ 60˚; iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm. The GORE® EXCLUDER® AAA Endoprosthesis extenders (Aortic and Iliac) are intended to be used after deployment of the GORE® EXCLUDER® AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired. CONTRAINDICATIONS: The GORE® EXCLUDER® AAA Endoprosthesis is contraindicated in: patients with known sensitivities or allergies to the device materials and patients with a systemic infection who may be at increased risk of endovascular graft infection. 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® EXCLUDER® Conformable AAA Endoprosthesis

INDICATIONS FOR USE UNDER CE MARK: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: adequate iliac/femoral access; infrarenal aortic neck treatment diameter range of 16–32 mm; a minimum aortic neck length of 10 mm when proximal aortic neck angulation is ≤ 60˚ and a minimum aortic neck length of 15 mm when proximal aortic neck angulation is ≤ 90˚; iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm. The Aortic Extenders and Iliac Extenders are intended to be used after deployment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired. The GORE® EXCLUDER® Conformable AAA Endoprosthesis is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and post-operative follow-up imaging. The GORE® EXCLUDER® Conformable AAA Endoprosthesis is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements. The GORE® EXCLUDER® Conformable AAA Endoprosthesis is not recommended in patients with known sensitivities or allergies to ePTFE, FEP, gold, nickel or titanium. CONTRAINDICATIONS: Contraindicated in patients with known sensitivities or allergies to the device materials and in patients with a systemic infection who may be at increased risk of endovascular graft infection. 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® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

INDICATIONS FOR USE UNDER CE MARK: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is intended to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: adequate iliac/femoral access; minimum common iliac diameter of 17 mm at the proximal implantation zone of the Iliac Branch Endoprosthesis; external Iliac artery treatment diameter range of 6.5–25 mm and seal zone length of at least 10 mm; internal iliac artery treatment diameter range of 6.5–13.5 mm and seal zone length of at least 10 mm. Warnings and precautions: The GORE® EXCLUDER® Iliac Branch Endoprosthesis is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and post-operative follow-up imaging. The GORE® EXCLUDER® Iliac Branch Endoprosthesis is not recommended in patients exceeding weight and/or size limits which compromise or prevent the necessary imaging requirements. The GORE® EXCLUDER® Iliac Branch Endoprosthesis is not recommended in patients with known sensitivities or allergies to ePTFE, FEP, nickel or titanium. CONTRAINDICATIONS: Contraindicated in patients with known sensitivities or allergies to the device materials and patients with a systemic infection who may be at increased risk of endovascular graft infection. 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® Molding and Occlusion Balloon Catheter (MOB)

INDICATIONS FOR USE UNDER CE MARK: The GORE® Molding & Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist the expansion of self-expanding endovascular prostheses (stent grafts). CONTRAINDICATIONS: The GORE® Molding & Occlusion Balloon Catheter is contraindicated in patients who: are contraindicated to contrast media or anticoagulants; have an arterial entry site that cannot accommodate a 10 Fr introducer sheath; are minors; are pregnant. 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® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

INDICATIONS FOR USE UNDER CE MARK: The GORE® TAG® Conformable Thoracic Stent Graft is intended for endovascular repair of the descending thoracic aorta. The GORE® TAG® Conformable Thoracic Stent Graft is indicated for endovascular repair of all lesions of the descending thoracic aorta, including isolated lesions (such as aneurysms and transections) and Type B dissections. CONTRAINDICATIONS: patients with known sensitivities or allergies to the device materials and patients with a systemic infection who may be at risk of endovascular graft infection. 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® TAG® Thoracic Branch Endoprosthesis (TBE)

INDICATIONS FOR USE UNDER CE MARK: The GORE® TAG® Thoracic Branch Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta (including isolated lesions, such as aneurysm and traumatic transection, and Type B dissections) while maintaining flow into the left subclavian artery, in patients who have appropriate anatomy. CONTRAINDICATIONS: The GORE® TAG® Thoracic Branch Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the device materials (see Product components), patients who have a condition that threatens to infect the graft and 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® Tri-Lobe Balloon Catheter

INDICATIONS FOR USE UNDER CE MARK: The GORE® Tri-Lobe Balloon Catheter is intended to facilitate in the endovascular repair of the thoracic or abdominal aorta due to lesions including aneurysms, dissections, trauma, and penetrating aortic ulcers. 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

231214937-EN

Residents of some states have the right to opt-out of the “sharing” or “selling” of their personal information. Gore does not "sell" the personal information of website users. Gore may "share" the personal information of website users, as standard advertising practice meant to offer you a more personalized service.

If you want to opt-out from Gore “sharing” your personal information, click on Opt-Out of Sharing to turn off the targeting cookies that we share with our advertising partners in order to provide you with personalized information. Disabling sharing will stop the use of cookies to targeted advertising but you may still see generic Gore ads.

Please note that your exercising of the rights outlined will have no adverse effect on the price and quality of our goods or services.

Opt-Out of Sharing

You Have Successfully Opted Out of the Sharing of Your Personal Information

Please note that if you clear your cookies and then use another device or browser, etc. your opt-out status is not transferred to the new device or browser.