Catalogue numbers for GORE® EXCLUDER® Iliac Branch Endoprosthesis

GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Branch Component
Catalogue Number Diameter Iliac End (mm) Iliac Branch Component Length (cm)
CEB231010A 10 10
CEB231210A 12 10
CEB231410A 14.5 10

 

Internal Iliac Component
Catalogue Number Diameter Iliac End (mm) Iliac Branch Component Length (cm)
HGB161007A 10 7
HGB161207A 12 7
HGB161407A 14.5 7

 

GORE® DRYSEAL Flex Introducer Sheath
Catalogue Number Sheath Size (Fr) Minimum Sheath ID (mm) Nominal Sheath OD (mm) Working Length (cm)
DSF1233 12 4.0 4.7 33
DSF1245 12 4.0 4.7 45
DSF1433 14 4.7 5.3 33
DSF1533 15 5.0 5.6 33
DSF1633 16 5.3 6.1 33
DSF1833 18 6.0 6.7 33
DSF2033 20 6.7 7.5 33
DSF2065 20 6.7 7.5 65
DSF2233 22 7.3 8.2 33
DSF2265 22 7.3 8.2 65
DSF2433 24 8.0 8.8 33
DSF2465 24 8.0 8.8 65
DSF2633 26 8.7 9.5 33
DSF2665 26 8.7 9.5 65

 

GORE® Molding & Occlusion Balloon
Catalogue Number Balloon inflation range (mm) Balloon length (cm) Catheter length (cm) Wire compatibility
MOB37 10-37 4 90 0.035

 

eIFU Symbol

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. 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® DRYSEAL Flex Introducer Sheath
INDICATIONS FOR USE IN THE U.S.: 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® Molding and Occlusion Balloon Catheter (MOB)
INDICATIONS FOR USE IN THE U.S.: The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large diameter vessels or to assist the expansion of self-expanding endovascular prostheses (stent grafts). CONTRAINDICATIONS: The GORE® Molding and 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

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