Skip to main content

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.

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.

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

Image
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

Image
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.

First-of-its kind FDA / MDR CE MARK approved device designed for simplified, minimally invasive Zone 2 TEVAR procedures. Deliver results without the potential risk and complexity of revascularization. 

Off-the-shelf endovascular grafts are preferable to traditional surgical options for LSA preservation 

    Single procedure

    arrow-narrow-down-blue

    4 days

    average reduction in length of stayd

    clock-green

    30 - 50 minutes

    potential reduction in OR timed,1

    Pivotal trial outcome. One year follow-up.

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

      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 representatives' 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.

      Image
      Doctor showing nurse information on tablet

      Related to this product:


      a Did not require intervention.
      b Core lab reported, 3 year (Total Through 36 Months(1-1275 days)).
      c Embolization and thoracic stent graft placement were the reinterventions.
      d 100% freedom from reintervention due to loss of LSA patency.

      1. Butterfield K, Hsu M, Powis S, Thon M. Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch (Pivotal): Zone 0/1. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2024. [Pre-Market Approval Study Report]. MD200865. Rev 1.
      2. Data on file 2024; W. L. Gore & Associates, Inc; Flagstaff, AZ.
      3. Brown J, Gorman J, Sondreaal M, Powis S. Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Descending Thoracic Aorta (Pivotal): Zone 2. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2021. [SSB 11-02 Pivotal Pre-Market Approval Study Report]. MD185099. Rev 1. 

      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 market where this product is available. RXOnly

      INDICATIONS FOR USE IN EUROPE: The GORE® TAG® Thoracic Branch Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta (including isolated lesions, such as aneurysm and traumatic transection, and Type B dissections) while maintaining flow into the left subclavian artery, in patients who have appropriate anatomy.

      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.  

      Product may not be available in all countries. Please check with your Gore representative for availability.