GORE® TAG® Thoracic Branch Endoprosthesis
A simplified solution within reach
First-of-its kind FDA-approved device designed for simplified, minimally invasive Zone 2 TEVAR procedures. Maximize results without the potential risks and complexity of revascularization.
IDE Study outcomes. One-year follow-up.
National Principal Investigators Himanshu Patel, M.D. and Michael Dake, M.D. share their perspectives on impact to LSA preservation procedures.
How a new branch technology for zone 2 treatment impacted one patient's life.
Related to this product:
* For patients treated with TBE compared to those treated TEVAR and surgical LSA revascularization
† Data on file 2023; W. L. Gore & Associates, Inc; Flagstaff, AZ.
- GORE® TAG® Thoracic Branch Endoprosthesis. [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2022. MD184153. Rev.
- GORE® DRYSEAL® Flex Introducer Sheath [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2021. MD179444.
- GORE® TAG® Conformable Thoracic Stent Graft [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2021. MD164940.
- GORE® TAG® Thoracic Branch Endoprosthesis (TBE) [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2022. MD184153.
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® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who have: Adequate iliac/femoral access; Proximal Aortic Landing Zones: For Isolated Lesion Patients: Proximal landing zone cannot be aneurysmal, dissected, heavily calcified or heavily thrombosed; For Dissection Patients: Primary entry tear must be distal to the left subclavian artery and the proximal extent of the landing zone must not be dissected; Aortic inner diameter range 16-42 mm; Proximal segment length (length from distal edge of left subclavian artery to mid left common carotid ostium) of at least 2.0-4.0 cm, depending on Aortic Component selection; Proximal covered length (measured from distal edge of left subclavian artery to distal edge of left common carotid artery ostium) of at least 15–36 mm, depending on Aortic Component selection; For patients with prior ascending aorta or aortic arch repair with surgical graft: at least 2 cm landing zone proximal to the distal anastomosis; Left Subclavian Landing Zone: Landing zone cannot be aneurysmal, dissected, heavily thrombosed and severely tortuous (180 degree turn within the treated length); Left subclavian artery inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected; Left subclavian artery minimum length of 2.5–3.0 cm, depending on Side Branch Portal diameter selected. Distal Landing Zone (Isolated Lesion Patients only): Outer curve length must be ≥ 2 cm proximal to celiac artery; Aortic inner diameter range 16-42 mm; Non aneurysmal, dissected, heavily calcified or heavily thrombosed landing zone; Native Aorta or previously placed GORE® TAG® Conformable Thoracic Stent Graft.
CONTRAINDICATIONS: The GORE® TAG® Thoracic Branch Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the device materials [ePTFE (polytetrafluoroethylene), FEP (fluoroethylpropylene), Nitinol (nickel, titanium), Gold, SB Component only - Heparin (CBAS® Heparin Surface)]; Patients who have a condition that threatens to infect the graft; Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.