GORE^® EXCLUDER^® Thoracoabdominal Branch Endoprosthesis (TAMBE)

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.