GORE® EXCLUDER® Iliac Branch Endoprosthesis
Preserve Flow.
Advance Care.
The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is the only FDA approved, off-the-shelf iliac branch solution and is designed to preserve blood flow to external and internal iliac arteries.
See the results:
IDE Study Outcomes. Five-year follow-up*
100% patency†
external iliac artery
95.1% patency†
internal iliac artery
98.3%
freedom from CIAA‡ enlargement†
95.2%
freedom from IBE-related reintervention
0%
buttock claudication‡
new onset erectile dysfunction
ZERO
type I/III endoleaks† migrations†
* U.S. IDE Clinical Trial. Sixty-three subjects with device implanted in initial cohort. Thirty-six patients have completed five-year follow-up.
† Core Lab reported assessment for patency, endoleak, migration and CIAA enlargement (> 5mm). Denominator is number of subjects evaluated for primary effectiveness endpoint result with an evaluable result.
‡ On the side treated with the IBE.
Why preservation matters
The recommended treatment1,2 to sustain quality of life
The GORE® EXCLUDER® Iliac Branch Endoprosthesis can be used with the GORE® EXCLUDER® AAA Endoprosthesis or GORE® EXCLUDER® Conformable AAA Endoprosthesis to create an off-the-shelf solution you can count on.
The next generation in aortic accessories
Related to this product
- Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. Journal of Vascular Surgery 2018;67(1):2-77.e2.
- Moll FL, Powell JT, Fraedrich G, et al. European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European Society for Vascular Surgery. European Journal of Vascular & Endovascular Surgery 2011;41(Supplement 1):S1-S58.
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
INDICATIONS FOR USE IN EUROPE: Iliac Branch and Internal Iliac Components. 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 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; Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Components; The Trunk-Ipsilateral Leg and Contralateral Leg Endoprostheses are intended to provide proximal seal and fixation to the GORE® EXCLUDER® Iliac Branch Endoprosthesis following deployment of the GORE® EXCLUDER® Iliac Branch Endoprosthesis. For more information on the Trunk-Ipsilateral Leg and Contralateral Leg Endoprosthesis Component indications for use and deployment, see the GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Conformable Endoprosthesis Instructions For Use.
Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components. The Aortic and Iliac Extender Endoprostheses can be used after deployment of the GORE® EXCLUDER® Iliac Branch and AAA Endoprostheses. 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 and 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 material and patients with a systemic infection who may be at increased risk of endovascular graft infection.