Approved across all aortic arch zones

The off-the-shelf, single branch device physicians trust for Zone 2 branched TEVAR procedures is now also approved for Zones 0 and 1, expanding minimally invasive repair of all lesions involving the aortic arch.

Diagram showing the anatomy of the aortic arch showing zone 0
Diagram showing the anatomy of the aortic arch showing zone 1
Diagram showing the anatomy of the aortic arch showing zone 2

Zones 0 and 1 approved

TBE provides an alternative to open surgical repair and reduces the overall impact of procedures like sternotomy, cardiopulmonary bypass and circulatory arrest.

98.6%

Side branch patency through 1 year1

Zone 0: n = 0 occlusions

Zone 1: n = 1 occlusiona
 

7.8%

Overall disabling stroke rate through 30 days1

Download more data

Of the 77 patients enrolled in the Zone 0/1 pivotal trial, more than 90% were treated in Zone 0 with no instances of device migration or wire fracture through 12 months, as well as low rates of Type I and III endoleaks.

Michael Dake, M.D., National Co-Principal Investigator of the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial

Michael Drake headshot smiling

We’ve seen firsthand how this technology can transform patient care. With a less invasive approach, we can reduce a significant procedural burden on patients.

Himanshu Patel, M.D., National Co -Principal Investigator

Headshot of Himanshu Patel

Zone 2 proven

TBE offers a demonstrated solution that preserves flow to the left subclavian artery (LSA) without the potential risks and complexity of surgical revascularization.

99.2%

LSA branch patency through 1 year1

3.6%

Disabling stroke rate, in aneurysm cohort, through 30 days1

Download more data

Whether it’s Zone 0, 1 or 2, consider TBE for your next aortic arch repair.

    How single-branch technology impacted one patient’s life.

      We're here to support you

      Reimbursement & Coding Resources

      Related to this product:

      a Did not require intervention.

      1. GORE® TAG® Thoracic Branch Endoprosthesis [Instructions for Use] W. L. Gore & Associates; 2025. MD205141.
      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: The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel 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 target branch vessel 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 target branch vessel to the midpoint of any proximal branch vessel) of at least 2.0-4.0 cm, depending on Aortic Component selection; Proximal covered length (measured from distal edge of target branch vessel to the distal edge of any proximal branch vessel) 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; Target Branch Vessel Landing Zone: Landing zone cannot be aneurysmal, dissected, heavily thrombosed and severely tortuous (180 degree turn within the treated length); Target branch vessel inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected; Target branch vessel 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; Cannot be aneurysmal, dissected, heavily calcified or heavily thrombosed; 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.

      24AR1132-EN03