Clinical outcomes Endurant™ stent graft systems
ENGAGE OUS Registry: 10 years of evidence with longest-term follow-up of any global EVAR registry
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The Endurant family of products have been chosen by physicians to treat more than half a million patients worldwide.1
As the first and only EVAR (endovascular aortic repair) system with a decade of global registry outcomes, Endurant systems continue to prove durability and strength in evidence with consistently high sac regression and low aneurysm-related mortality (ARM).2
Choose the standard of EVAR durability.
Quick links to clinical outcomes sections
- Clinical experience overview
- Event rates at 30 days across 1400+ patients
- ENGAGE OUS Registry: 10 years of evidence with longest-term follow-up of any global EVAR registry
- ENGAGE OUS Registry: 8 years of proven durability with durable patient outcomes
- ENGAGE OUS Registry: 5 years of real-world clinical excellence
- ENGAGE OUS Registry through 5 years
- Results of the Endurant US IDE study (Bifur)
- Procedural performance beyond clinical performance
| Trials and registries Endurant FIM study |
Duration (years)1 |
N (total patients: 1896)81 |
| Trials and registries Endurant France post-markup study |
Duration (years)5 |
N (total patients: 1896)180 |
| Trials and registries De novo cohort of ENGAGE PAS (US) |
Duration (years)5 |
N (total patients: 1896)178 |
| Trials and registries ENGAGE OUS registry full cohort |
Duration (years)5 |
N (total patients: 1896)1263 |
| Trials and registries ENGAGE OUS registry extended cohort |
Duration (years)10 |
N (total patients: 1896)390 |
| Trials and registries Endurant US IDE study (AUI) |
Duration (years)5 |
N (total patients: 1896)44 |
| Trials and registries Endurant US IDE study (Bifur) |
Duration (years)5 |
N (total patients: 1896)150 |
| Trials and registries Endurant FIM study4 |
Trial study design Prospective, open-label, multicenter trial conducted at 10 sites across Germany and the Netherlands. |
Technical/ 100 |
Type I endoleak (%) 0 |
| Trials and registries Endurant US IDE study (Bifur)5 |
Trial study design Prospective, multicenter trial conducted at 26 sites across the United States. |
Technical/ 99.3 |
Type I endoleak (%) 0 |
| Trials and registries ENGAGE OUS registry6 |
Trial study design Post-market, real-world registry involving 1263 patients at 79 sites in 30 countries. |
Technical/ 99.0 |
Type I endoleak (%) 1.2 |
| 10-year clinical outcomes Aneurysm-related mortality† |
%FF 94.7% |
| 10-year clinical outcomes Aneurysm-related reinterventions††* |
%FF 70.3% |
| 10-year clinical outcomes AAA sac regression‡ |
%64.1% (107/167) |
| 10-year clinical outcomes Type la endoleaks‡ |
%4.7% (8/172) |
| 10-year clinical outcomes Main body migration‡ |
% 1.3% (1/77) |
| 8-year clinical outcomes (N=390) Aneurysm-related mortality† |
%FF 99.5% |
| 8-year clinical outcomes (N=390) Secondary endovascular procedure† (overall) |
%FF 75.8% |
| 8-year clinical outcomes (N=390) AAA sac regression‡ |
%66.1% (166/251) |
| 8-year clinical outcomes (N=390) Type la endoleaks‡ |
%3.4% (9/261) |
| 8-year clinical outcomes (N=390) Main body migration‡ |
% 0.8% (1/127) |
| Aneurysm-related mortality§ | FF 97.8% |
| Secondary endovascular procedure§ (overall) | FF 84.3% |
| AAA sac regression|| | 61.4% |
| Type la endoleaks|| | 1.6% (8/501) |
| Main body migration|| | 0.3% (1/291) |
| Cumulative through 5 yearsFF secondary endovascular procedure¶ | 10 mm – < 15 mm |
≥ 15 mm (N = 1100)84.4% |
| Cumulative through 5 yearsFF ARM¶ | 10 mm – < 15 mm |
≥ 15 mm (N = 1100)97.8% |
| Cumulative through 5 yearsFF type la endoleak# | 10 mm – < 15 mm |
≥ 15 mm (N = 1100)96.0% |
| Cumulative through 5 yearsFF rupture§ | 10 mm – < 15 mm |
≥ 15 mm (N = 1100)98.7% |
| Cumulative through 5 yearsFF conversion§ | 10 mm – < 15 mm |
≥ 15 mm (N = 1100)98.0% |
| Clinical outcomes Type I/III endoleak** |
1 year0.0% (0/132) | 5 year0.0% (0/73) |
| Clinical outcomes Type II endoleak** |
1 year9.1% (12/132) | 5 year4.1% (3/73) |
| Clinical outcomes Migration |
1 year0.0% (0/135) | 5 year0.0% (0/83) |
| Clinical outcomes Conversion |
1 year FF 100% |
5 year FF 100% |
| Clinical outcomes Secondary procedure |
1 yearFF 95.3% | 5 yearFF 89% |
| Clinical outcomes Aneurysm-related mortality |
1 yearFF 100% | 5 yearFF 99.2% |
| Outcomes from the Endurant US IDE study (Bifur) Successful delivery and deployment |
At implant 99.3% |
| Outcomes from the Endurant US IDE study (Bifur) Procedure duration (minutes) |
At implant 101.5 |
| Outcomes from the Endurant US IDE study (Bifur) General anesthesia |
At implant 83.3% |
| Outcomes from the Endurant US IDE study (Bifur) Blood loss (mL) |
At implant 185.8 |
| Outcomes from the Endurant US IDE study (Bifur) ICU stay (hours) |
At implant 6.2 |
| Outcomes from the Endurant US IDE study (Bifur) Hospital stay (days) |
At implant 2.1 |
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*
Aneurysm-related re-interventions are defined as all the secondary endovascular procedures (scheduled and unscheduled), secondary vascular procedures and conversions to open repair.
†
Data reported through ten-year time frame with full +extended cohort, determined by Clinical Event Committee.
‡
Data reported at ten-year time frame with extended cohort.
§
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 reported through ten-year time frame with full +extended cohort.
References
1
Data on file at Medtronic. Data current as of March 2023.
2
Verhagen et al. The ENGAGE Registry: Ten-Year Outcomes with the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair. Presented at: Charing Cross 2023 International Symposium; April 26, 2023; London, UK.
3
Data on file at Medtronic. Data current as of April 2023.
4
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.
5
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.
6
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.
7
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.
8
ENGAGE five-year data. Data on file at Medtronic.
9
Data on file at Medtronic.