GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) Pivotal Study Outcomes
Evidence through 1 year
Powered for proof
The TAMBE Pivotal Study1 is the only prospective, multi-site, CEC-adjudicated study for an approved thoracoabdominal endovascular solution.
- 102 primary arm patients
- 44 trial sites worldwide
- 60+ participating surgeons
TAMBE was evaluated by a large, diverse group of skilled surgeons across a wide range of patient populations.
High device effectiveness2
100%
freedom
from lesion-related mortality
94.1%
freedom
from aneurysm growth
Zero
conversions to open repair
Zero
reported device migrations
High technical success3
One-year outcomes build on proven early procedural results at 30 days, with 99% technical success3 per SVS reporting standards.4
- Median hospital stay following the procedure was 4 days.3
- No additional events of aortic rupture or permanent paraplegia occurred after 30 days and through 12 months.2
| 30-day clinical outcomes (n = 102)3 | Events (%) |
|---|---|
| Protocol-defined procedural safety events at 30 daysa,b | 8 (7.8%) |
| Stented segment aortic rupture | 1 (1.0%) |
| Lesion-related mortality | 0 (0.0%) |
| Permanent paraplegia | 2 (2.0%) |
| Permanent paraparesis | 3 (2.9%)c |
| New onset renal failure requiring dialysis | 2 (2.0%) |
| Severe bowel ischemia | 0 (0.0%) |
| Disabling stroke | 1 (1.0%) |
a. One patient had two events: paraplegia and stented segment aortic rupture (protocol defined) and intraoperative aortic rupture. Intraoperative aortic rupture was due to disruption of a narrow aortic bifurcation during balloon dilatation.
b. Adjudicated by the clinical events committee. Patients with at least 30-day post-procedure follow-up, or an event.
c. Two subjects who meet the protocol definition for permanent paraparesis had a full recovery by 6 months after the procedure.
High-risk anatomy2
Branch complications are a known risk in BEVAR. Contributing factors of branch occlusions may include tortuosity, clock-angle offset, minimum aortic diameter, vessel position and orientation, compression and total branch length; however, renal artery size was the only statistically significant risk factor identified.
| Event, n (%) | Total No. of vesselsd N = 368 | Renal – left n = 90 | Renal – right n = 89 | Celiac n = 95 | SMA n = 94 |
|---|---|---|---|---|---|
| Any target vessel instability | 23 (6.3) | 10 (11.1) | 9 (10.1) | 1 (1.1) | 3 (3.2) |
| Occlusion/stenosis overall | 20 (5.4) | 8 (8.9) | 8 (9.0) | 1 (1.1) | 3 (3.2) |
Abbreviations: No. = number; SMA = superior mesenteric artery.
d. At 12 months, 95 patients completed a follow-up with imaging. The denominator for individual vessels and total vessel reflects that in some cases, not all vessels were successfully imaged (eg, unable to visualize vessel) and were, therefore, not included in the count.
Purpose built. Rigorously studied. TAMBE is delivering.
For additional 1-year data and analysis, read the full article published in the Journal of Vascular Surgery.
- U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED) for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA P230023B). U.S. Department of Health and Human Services; January 12, 2024. Accessed February 24, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230023B.pdf
- Farber, Mark A. et al. 1-year Results from the Pivotal Trial of a 4-Branch Thoracoabdominal Branch Endoprosthesis. Journal of Vascular Surgery, Volume 81, Issue 6, e236.
- Farber MA, Matsumura JS, Han S, et al. Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms. Journal of Vascular Surgery. 2024;80(5):1326-1335.e4. doi:10.1016/j.jvs.2024.05.020
- Oderich GS, Forbes TL, Chaer R, et al. Reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries. Journal of Vascular Surgery, 2021;73(1S):4S-52S.
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 EUROPE: The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and pararenal aortic aneurysms who have appropriate anatomy.
CONTRAINDICATIONS: The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is contraindicated in patients with known sensitivities or allergies to TAMBE materials including ePTFE FEP nickel titanium alloy (Nitinol) stainless steel and gold. It is also contraindicated in patients who have a condition that threatens to infect the graft. Additionally patients with known hypersensitivity to heparin — including those who have previously experienced heparin-induced thrombocytopenia (HIT) type II and cannot receive the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis — should not receive this device.