GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)
The first FDA-approved, off-the-shelf, endovascular repair solution for the treatment of complex aneurysmal disease involving the visceral aorta.
IDE Study Outcomes. One-year follow-up1
IDE Study Outcomes. One-year follow-up1
“TAMBE marks a significant development in the options at our disposal for complex aneurysmal disease. We now possess the ability to provide for on-label care for patients that is minimally invasive and clinically proven, and we can do so without delay for device manufacturing or modifications.”
— Mark A. Farber, M. D.
With dedicated support you can depend on in complex procedures:
- Training needs – Essential technical support with a deep reservoir of product knowledge.
- Our field representatives support hundreds of aortic cases per year, building on diverse clinical backgrounds.
- Non-commissioned sales force – Our focus is on outcomes.
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Basic information about thoracoabdominal disease and treatment options
1. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2023. MD193085
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. 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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