GORE® TAG® Thoracic Branch Endoprosthesis
A simplified solution within reach
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.
Zero
Zero device migration, zero wire fracture through 1 year1
1.5%
Type Ia endoleaks through 1 year.
No protocol defined reinterventions for Type Ia endoleaks1
93.5%
Freedom from reintervention through 1 year (protocol defined reintervention)1
100%
Freedom from permanent paraplegia, paraparesis through 30 days1
98.6%
Side branch patency through 1 year1
• Zone 0: n = 0 occlusions
• Zone 1: n = 1 occlusiona
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.
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.
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.
Zero
Zero device migration, zero wire fracture through 1 year3
1.3%
Type 1a endoleaks through 3 yearsb
2 protocol defined reinterventionsc for Type Ia endoleaks2
97.1%
Freedom from reintervention through 1 year (protocol defined reintervention)3
99%
Freedom from permanent paraplegia, paraparesis through 30 days3
99.2%
LSA branch patency through 3 years2,b
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
4 days
average reduction in length of stayd
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.
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.
- 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.
- Data on file 2024; W. L. Gore & Associates, Inc; Flagstaff, AZ.
- 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.
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.