Clinical Outcomes Endurant™ AAA stent graft systems

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.

2020 annual physician clinical update

Endurant and Endurant II/IIs stent graft system

Endurant II, Endurant IIs, and Endurant AUI stent grafts on transparent background

Clinical experience overview3

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 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
 
 

Event rates at 30 days across 1,400+ patients

Trials and registries

Trial study design

Technical/
deployment 
success (%)

Type I endoleak (%)

Endurant FIM study4
(N = 81)

Prospective, open-label, multicenter trial conducted at 10 sites across Germany and the Netherlands.

100

0

Endurant US IDE study (Bifur)5
(N = 150)

Prospective, multicenter trial conducted at 26 sites across the United States. 

99.3

0

ENGAGE OUS registry6
(N = 1,263)

Post-market, real-world registry involving 1,263 patients at 79 sites in 30 countries.

99.0

1.2

 

ENGAGE OUS Registry: 10 years of evidence with longest-term follow-up of any global EVAR registry2

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)

 
 
 
 

ENGAGE OUS Registry: 8 years of proven durability with durable patient outcomes7

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)

 
 
 

ENGAGE OUS Registry: 5 years of real-world clinical excellence8

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)
 
 

The ENGAGE OUS registry through five years: short neck cohort9

Cumulative through 5 years

10 mm – < 15 mm
(N = 123)

≥ 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%

Results of the Endurant US IDE study (Bifur)4,9

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%
 

Procedural performance beyond clinical performance9

Outcomes from the Endurant US IDE study (Bifur)

At implant

Successful delivery and deployment

99.3%
(149/150)

Procedure duration (minutes)
(mean + SD; N = 150)

101.5
+ 46.2

General anesthesia

83.3%
(125/150)

Blood loss (mL)
(mean + SD; N = 149)

185.8
+ 168.0

ICU stay (hours)
(mean + SD; N = 150)

6.2 
+ 19.4

Hospital stay (days)
(mean + SD; N = 150)

2.1 
+ 2.3

Resources

pdf Five-year ENGAGE gender analysis Schermerhorn deck (.pdf)

Five years makes a difference — Endurant is the only stent graft to show comparable outcomes between men and women at five years.

1.8MB

Aortic catalog

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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.