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The Endurant family of products provides the standard of care with a legacy of clinical success for the treatment of abdominal aortic aneurysm (AAA). Only the Endurant family of products, designed to address sac regression,1 has the deep clinical experience, favorable outcomes, and the most validated data on any single graft for everyday or extraordinary challenges. For the past five years, the Endurant II/IIs has been used in 1 out of 3 EVAR cases,1 with use in more than 450,000 patients worldwide.1
Endurant and Endurant II/IIs stent graft system
Trials and registries | Duration (years) |
N (total patients: 1,896) |
---|---|---|
Endurant FIM study |
1 | 81 |
Endurant France post-markup study |
5 | 180 |
De novo cohort of ENGAGE PAS (US) |
5 | 178 |
ENGAGE OUS registry 5-year cohort |
8 | 1263 |
ENGAGE OUS registry extended cohort |
10* | 390 |
Endurant US IDE study (AUI) |
5 | 44 |
Endurant US IDE study (Bifur) |
5 | 150 |
Trials and registries |
Trial study design |
Technical/ |
Type I endoleak (%) |
---|---|---|---|
Endurant FIM study3 |
Prospective, open-label, multicenter trial conducted at 10 sites across Germany and the Netherlands. |
100 |
0 |
Endurant US IDE study (Bifur)4 |
Prospective, multicenter trial conducted at 26 sites across the United States. |
99.3 |
0 |
ENGAGE OUS registry5 |
Post-market, real-world registry involving 1,263 patients at 79 sites in 30 countries. |
99.0 |
1.2 |
8-year clinical outcomes |
% |
---|---|
Aneurysm-related mortality† | FF 99.5% |
Secondary endovascular procedure† (overall) | 75.8% |
AAA sac diameter decrease‡ | 66.1% (166/251) |
Type la endoleaks‡ | 3.4% (9/261) |
Main body migration‡ | 0.8% (1/127) |
Clinical outcomes |
% |
---|---|
Aneurysm-related mortality§ | FF 97.8% |
Secondary endovascular procedure§ (overall) | FF 84.3% |
AAA sac diameter decrease|| | 61.4% |
Type la endoleaks|| | 1.6% (8/501) |
Main body migration|| | 0.3% (1/291) |
Cumulative through 5 years | 10 mm – < 15 mm |
≥ 15 mm (N = 1100) |
---|---|---|
FF secondary endovascular procedure¶ | 84.5% | 84.4% |
FF ARM¶ | 97.8% | 97.8% |
FF type la endoleak# | 90.9%# | 96.0% |
FF rupture§ | 96.6% | 98.7% |
FF conversion§ | 96.5% | 98.0% |
Clinical outcomes |
1 year | 5 year |
---|---|---|
Type I/III endoleak** | 0.0% (0/132) | 0.0% (0/73) |
Type II endoleak** | 9.1% (12/132) | 4.1% (3/73) |
Migration | 0.0% (0/135) | 0.0% (0/83) |
Conversion | 100% FF |
100% FF |
Secondary procedure | 95.3% FF | 89% FF |
Aneurysm-related mortality | 100% FF | 99.2% FF |
Outcomes from the Endurant US IDE study (Bifur) |
At implant |
---|---|
Successful delivery and deployment |
99.3% |
Procedure duration (minutes) |
101.5 |
General anesthesia |
83.3% |
Blood loss (mL) |
185.8 |
ICU stay (hours) |
6.2 |
Hospital stay (days) |
2.1 |
Choose from a complete portfolio of market-leading aortic vascular therapies to treat aneurysm disease.
Data available out to 8 years; patients continued to be followed out to 10 years.
Data reported through eight-year time frame determined by Clinical Event Committee.
Data reported at eight-year time frame.
Data reported through five-year time frame determined by Clinical Event Committee.
Data reported at five-year time frame.
Numbers are freedom from (FF) event survival estimate % based on Kaplan-Meier method.
Numbers are freedom from (FF) event survival estimate % based on interval-censored method.
(p < 0.05).
Data on file at Medtronic. Data current as of May 2017.
Data on file at Medtronic. Data current as of April 2021.
ENDURANT EU trial: Rouwet EV, Torsello G, de Vries J-P P, et al. Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. October 2011;42(4):489-497.
ENDURANT US IDE trial: Singh MJ, Fairman R, Anain P, et al. Final results of the Endurant Stent Graft System in the United States regulatory trial. J Vasc Surg. July 2016;64(1):55-62.
Teijink JAW, Power AH, Böckler D, et al. Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry. Eur J Vasc Endovasc Surg. August 2019;58(2):175-181.
Teijink J, Power A, van Sterkenburg S, et al. 8-Year Data from the ENGAGE Registry Extension: Insights About the Long-term Performance of A Contemporary EVAR Device. Presented online at ESVS 35th Annual Meeting. September 20, 2021.
ENGAGE five-year data. Data on file at Medtronic.
Data on file at Medtronic.