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Specifications

Aortic Component 
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Proximal diameter (mm) x distal diameter (mm) x length (mm)

Catalogue numberDevice sizeIntended proximal aortic
inner diameter (mm)
Recommended
sheath size (Fr)
ATAA43120160A31 x 20 x 16022–2922
ATAA43720160A37 x 20 x 16027–3422

 

Distal Bifurcated Component
GORE® EXCLUDER® Iliac Branch Endoprosthesis

Proximal diameter (mm) x distal diameter (mm) x length (cm)

Catalogue numberDevice sizeIntended iliac vessel
diameter (mm)
Recommended
sheath size (Fr)
CEB231010A23 x 10 x 108–916
CEB231210A23 x 12 x 1010–1116
CEB231410A23 x 14.5 x 1012–13.516

 

Branch Component 
GORE® VIABAHN® VBX® Balloon Expandable Endoprosthesis

Proximal diameter (mm) x distal diameter (mm) x length (mm)

Catalogue numberNominal device sizeFinal stent ID range
BXA053902A5 x 394.5–8.0
BXA055902A5 x 594.5–8.0
BXA057902A5 x 794.3–8.0
BXA063902A6 x 395.0–8.0
BXA065902A6 x 595.1–8.0
BXA067902A6 x 795.3–8.0
BXA073902A7 x 396.0–11.0
BXA075902A7 x 596.0–11.0
BXA077902A7 x 796.0–11.0
BXA083902A8 x 396.7–11.0
BXA085902A8 x 596.8–11.0
BXA087902A8 x 797.0–11.0
BXA093902A9 x 398.0–13.0
BXA095902A9 x 597.8–13.0
BXA097902A9 x 797.8–13.0

 

Contralateral Leg Component 
GORE® EXCLUDER® AAA Endoprosthesis

Distal diameter (mm) x length (cm)

Catalogue numberDevice sizeIntended iliac vessel
diameter (mm)
Recommended sheath size (Fr)
PLC12100012 x 1010–1112
PLC12120012 x 1210–1112
PLC12140012 x 1410–1112
PLC14100014.5 x 1012–13.512
PLC14120014.5 x 1212–13.512
PLC14140014.5 x 1412–13.512
PLC161000*16 x 9.513.5–14.512
PLC161200*16 x 11.513.5–14.512
PLC161400*16 x 13.513.5–14.512
PLC181000*18 x 9.514.5–16.512
PLC181200*18 x 11.514.5–16.512
PLC181400*18 x 13.514.5–16.512
PLC201000*20 x 9.516.5–18.512
PLC201200*20 x 11.516.5–18.512
PLC201400*20 x 13.516.5–18.512
PLC231000*23 x 1018.5–21.514
PLC231200*23 x 1218.5–21.514
PLC231400*23 x 1418.5–21.514
PLC271000*27 x 1021.5–25.015
PLC271200*27 x 1221.5–25.015
PLC271400*27 x 1421.5–25.015

 

Iliac Extender Endoprosthesis 
GORE® EXCLUDER®AAA Endoprosthesis

Distal diameter (mm) x length (cm)

Catalogue numberDevice sizeIntended iliac vessel
diameter (mm)
Recommended
sheath size (Fr)
PLL16100710 x 78.0–9.012
PLL16120712 x 710.0–11.012
PLL16140714.5 x 712.0–13.512

 

Distal Bifurcated Component Extender 
GORE® EXCLUDER® AAA Endoprosthesis

Distal diameter (mm) x length (cm)

Catalogue numberDevice sizeIntended proximal aortic
inner diameter (mm)
Recommended
sheath size (Fr)
PLA23030023 x 3.319–2116

 

GORE® DRYSEAL Flex Introducer Sheath

Catalogue numberSheath size (Fr)Nominal sheath OD (mm)
DSF1233124.7
DSF1245124.7
DSF1433145.3
DSF1533155.6
DSF1633166.1
DSF1833186.7
DSF2033207.5
DSF2233228.2

 

GORE® Tri-Lumen Catheter

Catalogue numberDevice length (cm)Size (Fr)
TLC1401407.5

 

GORE® Tri-Lobe Balloon Catheter

Catalogue numberSize (Fr)Vessel diameter (mm)
BCM16341816–32
BCL26451826–42

 

GORE® Molding & Occlusion Balloon

Catalogue numberSize (Fr)Balloon diameter (mm)
MOB371010–37

 

eIFU Symbol

* PLEASE NOTE: All large diameter Contralateral Leg Endoprostheses (16, 18, 20, 23, 27 mm) can be used as Iliac Extenders.

INDICATIONS FOR USE IN THE U.S.: The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy as described below: Adequate iliac/femoral access and brachial/axillary access; Proximal (supraceliac) aortic neck treatment diameter range over 2 cm seal zone of 22–34 mm for aneurysms extending up to 6.5 cm or less above the origin of the most proximal branch vessel; Aortic neck angle ≤ 60° at the Aortic Component proximal seal zone; Iliac artery treatment diameter range of 8–25 mm and iliac artery seal zone length of at least 10 mm; Renal artery seal zone diameters between 4.0–10.0 mm; Celiac and superior mesenteric artery seal zone diameters between 5.0–12.0 mm; ≥ 15 mm seal zone length in renal arteries, superior mesenteric artery, and celiac artery; Visceral segment of aorta (3 cm proximal through 9.5 cm distal to the most proximal visceral artery) must be ≥ 20 mm in diameter. CONTRAINDICATIONS: The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the TAMBE Device materials including ePTFE, FEP, nickel titanium alloy (Nitinol), stainless steel, and gold. Patients who have a condition that threatens to infect the graft. Patients with known hypersensitivity to heparin, including patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II and cannot receive the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. Refer to Instructions for Use at eifu.goremedical.comfor a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. 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 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

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

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

INDICATIONS FOR USE IN THE U.S.: The GORE® Tri-Lumen Catheter is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters and wires should be employed. 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

INDICATIONS FOR USE IN THE U.S.: The GORE® Tri-Lobe Balloon Catheter is indicated 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.  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 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

Sizing, availability, and pricing varies by country.
Please check with your Gore representative for availability.

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