Aortoiliac Aneurysms and Common Iliac Artery Aneurysms
In approximately 25 percent of patients with an abdominal aortic aneurysm (AAA), the aneurysm extends into at least one of the common iliac arteries.1 These are referred to as aortoiliac aneurysms. Additionally, the aneurysm may be isolated to the common iliac artery, which are referred to as common iliac artery aneurysms.
The size and location of an aortoiliac aneurysm or common iliac artery aneurysm and general health of the patient will determine how the aneurysm should be treated. In some cases, the physician may choose to block blood flow to (embolize) and cover the internal iliac artery to treat the aneurysm. While this is at times necessary, it often results in complications including buttock claudication and new onset sexual dysfunction.
SVS Clinical Practice Guidelines for patients with AAA2 include recommendations pertaining to internal iliac artery preservation during EVAR treatment. These recommendations include using a Food and Drug Administration (FDA) approved branch endograft in anatomically suitable patients to maintain perfusion to at least one internal iliac artery.
The GORE® EXCLUDER® Iliac Branch Endoprosthesis is the first branch endograft approved by the FDA*, designed for endovascular repair of aortoiliac or common iliac aneurysms while preserving flow to the internal iliac artery. It is used in conjunction with the GORE® EXCLUDER® AAA Endoprosthesis or GORE® EXCLUDER® Conformable AAA Endoprosthesis.
Products Related to Aortoiliac Aneurysms and Common Iliac Artery Aneurysms
* FDA approval 2016
- Carballeira J. Hypogastric Procedures Study. Parsippany, NJ: HRA — Healthcare Research & Analytics. 2011.
- Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with abdominal aortic aneurysm. Journal of Vascular Surgery 2018;67(1):2-77.e2.
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 IN THE U.S.: Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis. 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. Aortic Extender and Iliac Extender Endoprosthesis. The Aortic and Iliac Extender Endoprostheses 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; patients with a systemic infection who may be at increased risk of endovascular graft infection.
GORE® EXCLUDER® Conformable AAA Endoprosthesis
INDICATIONS FOR USE IN THE U.S.: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation and 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 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® Conformable Aortic Extender Endoprosthesis (Aortic Extender) is intended to be used after deployment of the GORE® EXCLUDER® Conformable Trunk-Ipsilateral Leg Component. The Aortic Extender is to be used when additional length and/or sealing for aneurysmal exclusion is desired.
CONTRAINDICATIONS: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is contraindicated in: patients with known sensitivities to allergies to the device materials. Patients with systemic infection who may be at increased risk of endovascular graft infection.
GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)
INDICATIONS FOR USE IN THE U.S.: Iliac Branch and Internal Iliac Components. The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is intended to be used with the GORE® EXCLUDER® AAA Endoprosthesis or the GORE® EXCLUDER® Conformable Endoprosthesis 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 IBE; 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; Adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components. GORE® EXCLUDER® Components used in conjunction with GORE® EXCLUDER® Iliac Branch Endoprosthesis: Trunk-Ipsilateral Leg Component. The Trunk-Ipsilateral Leg is intended to provide proximal seal and fixation for the endovascular repair of the aneurysm. For more information on the Trunk-Ipsilateral Leg Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis or the GORE® EXCLUDER® Conformable Endoprosthesis Instructions for Use. Contralateral Leg Endoprosthesis Component. The Contralateral Leg Endoprosthesis is intended to bridge the GORE® EXCLUDER® Device Trunk-Ipsilateral Component to the GORE® EXCLUDER® Iliac Branch Endoprosthesis following deployment of the GORE® EXCLUDER® Iliac Branch Endoprosthesis. Additionally, the Contralateral Leg Endoprosthesis is intended to be used for distal extension of the Iliac Branch Component in the external iliac artery. The Iliac Branch Component can treat external iliac artery diameters up to 13.5 mm. This ability to extend the Iliac Branch Component distally with any Contralateral Leg Endoprosthesis expands the external iliac artery treatment range up to 25 mm. For more information on the Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis Instructions for Use. Aortic Extender and Iliac Extender Components. The Aortic and Iliac Extender Components can be used after deployment of the GORE® EXCLUDER® Iliac Branch and GORE® EXCLUDER® AAA Endoprostheses or the GORE® EXCLUDER® Conformable Endoprosthesis. These extensions are used when additional length and/or sealing for aneurysmal exclusion is desired. For more information on Aortic Extender and Iliac Extender indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis or the GORE® EXCLUDER® Conformable Endoprosthesis Instructions for Use.
CONTRAINDICATIONS: The GORE® EXCLUDER® Iliac Branch Endoprosthesis is contraindicated in: patients with known sensitivities or allergies to the device materials. All components of the GORE® EXCLUDER® Iliac Branch Endoprosthesis, the GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Conformable Endoprosthesis contain ePTFE, FEP, nitinol (nickel-titanium alloy) and gold. Patients with a systemic infection who may be at increased risk of endovascular graft infection.