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 | Duration (years) |
N (total patients: 1896) |
|---|---|---|
| Endurant FIM study |
1 | 81 |
| Endurant France post-markup study |
5 | 180 |
| De novo cohort of ENGAGE PAS (US) |
5 | 178 |
| ENGAGE OUS registry full cohort |
5 | 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 study4 |
Prospective, open-label, multicenter trial conducted at 10 sites across Germany and the Netherlands. |
100 |
0 |
| Endurant US IDE study (Bifur)5 |
Prospective, multicenter trial conducted at 26 sites across the United States. |
99.3 |
0 |
| ENGAGE OUS registry6 |
Post-market, real-world registry involving 1263 patients at 79 sites in 30 countries. |
99.0 |
1.2 |
| 10-year clinical outcomes |
% |
|---|---|
| Aneurysm-related mortality† | FF 94.7% |
| Aneurysm-related reinterventions††* | FF 70.3% |
| AAA sac regression‡ | 64.1% (107/167) |
| Type la endoleaks‡ | 4.7% (8/172) |
| Main body migration‡ | 1.3% (1/77) |
| 8-year clinical outcomes (N=390) |
% |
|---|---|
| Aneurysm-related mortality† | FF 99.5% |
| Secondary endovascular procedure† (overall) | FF 75.8% |
| AAA sac regression‡ | 66.1% (166/251) |
| Type la endoleaks‡ | 3.4% (9/261) |
| Main body migration‡ | 0.8% (1/127) |
| Clinical outcomes (N=1263) |
% |
|---|---|
| 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 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 | FF 100% |
FF 100% |
| Secondary procedure | FF 95.3% | FF 89% |
| Aneurysm-related mortality | FF 100% | FF 99.2% |
| 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 |
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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.