Bridging the gap between thoracic and abdominal care

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 up.1

    100%

    Freedom from lesion-related mortality

    94.1%

    Freedom from all-cause mortality

    98%

    Freedom from paraplegiaa

    94.2%

    Freedom from target-vessel instability

    Read the full paper

    a. 30-day outcome

    “TAMBE marks a significant development in the options at our disposal for complex aneurysmal disease. We now possess the ability to provide 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.

    The next generation in aortic accessories 

    GORE® DRYSEAL Flex Introducer Sheath

    GORE® Tri-Lobe Balloon Catheter

    GORE® Molding & Occlusion Balloon

    Reimbursement & Coding Resources

    Related to this product

    1. Farber MA, Han S, Makaroun MS. 1-year outcomes from the pivotal trial of a four-branch off-the shelf solution to treat pararenal and Extent IV thoracoabdominal aortic aneurysms. Journal of Vascular Surgery. In press.
    IFU Consult instructions

    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. 

    GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) is not authorized for use in Canada.

    Products listed may not be approved in all markets. 
    24AR1136-EN03