GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) Specifications
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) is not authorized for use in Canada.
Aortic ComponentGORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | |||
|---|---|---|---|
| Proximal Diameter (mm) x Distal Diameter (mm) x Length (mm) | |||
| Catalogue Number | Device Size | Intended Proximal Aortic Inner Diameter (mm) | Recommended Sheath Size (Fr) |
| ATAA43120160A | 31 x 20 x 160 | 22–29 | 22 |
| ATAA43720160A | 37 x 20 x 160 | 27–34 | 22 |
Distal Bifurcated ComponentGORE® EXCLUDER® Iliac Branch Endoprosthesis | |||
|---|---|---|---|
| Proximal Diameter (mm) x Distal Diameter (mm) x Length (cm) | |||
| Catalogue Number | Device Size | Intended Iliac Vessel Diameter (mm) | Recommended Sheath Size (Fr) |
| CEB231010A | 23 x 10 x 10 | 8–9 | 16 |
| CEB231210A | 23 x 12 x 10 | 10–11 | 16 |
| CEB231410A | 23 x 14.5 x 10 | 12–13.5 | 16 |
Branch ComponentGORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | ||
|---|---|---|
| Nominal Stent Diameter (mm) x Crimped Stent Length (mm) | ||
| Catalogue Number | Nominal Device Size | Final Stent ID Range |
| BXA053902A | 5 x 39 | 4.5–8.0 |
| BXA055902A | 5 x 59 | 4.5–8.0 |
| BXA057902A | 5 x 79 | 4.3–8.0 |
| BXA063902A | 6 x 39 | 5.0–8.0 |
| BXA065902A | 6 x 59 | 5.1–8.0 |
| BXA067902A | 6 x 79 | 5.3–8.0 |
| BXA073902A | 7 x 39 | 6.0–11.0 |
| BXA075902A | 7 x 59 | 6.0–11.0 |
| BXA077902A | 7 x 79 | 6.0–11.0 |
| BXA083902A | 8 x 39 | 6.7–11.0 |
| BXA085902A | 8 x 59 | 6.8–11.0 |
| BXA087902A | 8 x 79 | 7.0–11.0 |
| BXA093902A | 9 x 39 | 8.0–13.0 |
| BXA095902A | 9 x 59 | 7.8–13.0 |
| BXA097902A | 9 x 79 | 7.8–13.0 |
Contralateral Leg ComponentGORE® EXCLUDER® AAA Endoprosthesis | |||
|---|---|---|---|
| Distal Diameter (mm) x Length (cm) | |||
| Catalogue Number | Device Size | Intended Iliac Vessel Diameter (mm) | Recommended Sheath Size (Fr) |
| PLC121000 | 12 x 10 | 10–11 | 12 |
| PLC121200 | 12 x 12 | 10–11 | 12 |
| PLC121400 | 12 x 14 | 10–11 | 12 |
| PLC141000 | 14.5 x 10 | 12–13.5 | 12 |
| PLC141200 | 14.5 x 12 | 12–13.5 | 12 |
| PLC141400 | 14.5 x 14 | 12–13.5 | 12 |
| PLC161000* | 16 x 9.5 | 13.5–14.5 | 12 |
| PLC161200* | 16 x 11.5 | 13.5–14.5 | 12 |
| PLC161400* | 16 x 13.5 | 13.5–14.5 | 12 |
| PLC181000* | 18 x 9.5 | 14.5–16.5 | 12 |
| PLC181200* | 18 x 11.5 | 14.5–16.5 | 12 |
| PLC181400* | 18 x 13.5 | 14.5–16.5 | 12 |
| PLC201000* | 20 x 9.5 | 16.5–18.5 | 12 |
| PLC201200* | 20 x 11.5 | 16.5–18.5 | 12 |
| PLC201400* | 20 x 13.5 | 16.5–18.5 | 12 |
| PLC231000* | 23 x 10 | 18.5–21.5 | 14 |
| PLC231200* | 23 x 12 | 18.5–21.5 | 14 |
| PLC231400* | 23 x 14 | 18.5–21.5 | 14 |
| PLC271000* | 27 x 10 | 21.5–25.0 | 15 |
| PLC271200* | 27 x 12 | 21.5–25.0 | 15 |
| PLC271400* | 27 x 14 | 21.5–25.0 | 15 |
Iliac Extender EndoprosthesisGORE® EXCLUDER® AAA Endoprosthesis | |||
|---|---|---|---|
| Distal Diameter (mm) x Length (cm) | |||
| Catalogue Number | Device Size | Intended Iliac Vessel Diameter (mm) | Recommended Sheath Size (Fr) |
| PLL161007 | 10 x 7 | 8.0–9.0 | 12 |
| PLL161207 | 12 x 7 | 10.0–11.0 | 12 |
| PLL161407 | 14.5 x 7 | 12.0–13.5 | 12 |
Distal Bifurcated Component ExtenderGORE® EXCLUDER® AAA Endoprosthesis | |||
|---|---|---|---|
| Distal Diameter (mm) x Length (cm) | |||
| Catalogue Number | Device Size | Intended Proximal Aortic Inner Diameter (mm) | Recommended Sheath Size (Fr) |
| PLA230300 | 23 x 3.3 | 19–21 | 16 |
Sizing, availability, and pricing varies by country.
Please check with your Gore representative for availability.
* PLEASE NOTE: All large diameter Contralateral Leg Endoprostheses (16, 18, 20, 23, 27 mm) can be used as Iliac Extenders.
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® 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; and 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 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.
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. The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is also indicated for use with thoracoabdominal and pararenal branched devices indicated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a branch component.*
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.
* Not applicable to Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXB catalogue numbers.)
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.
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.