GORE® TAG® Thoracic Branch Endoprosthesis
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.
“The GORE® TAG® Thoracic Branch Endoprosthesis has the potential to simplify the treatment of Zone 2 LSA revascularization because it is a single device that can be used in a single procedure.”
Michael Dake, M.D.,
Co-national principal investigator
National Principal Investigators Himanshu Patel, M.D. and Michael Dake, M.D. share their perspectives on impact to LSA preservation procedures.
From pre-case planning to device procedural consultation, we are by your side to provide support.
- Training needs — Essential technical support with a deep reservoir of product knowledge.
- 8+ years — Average field Associates' tenure supporting Gore's aortic devices, building on diverse clinical backgrounds.
- Non-commissioned sales force — Our focus is on outcomes.
Contact your Gore Field Sales Associate to learn more.
* For patients treated with TBE compared to those treated TEVAR and surgical LSA revascularization
- GORE® TAG® Thoracic Branch Endoprosthesis. [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2022. MD184153. Rev. 2.
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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. 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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