Clinical Outcomes Endurant™ II Stent Graft Systems

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

2020 annual physician clinical update

Endurant and Endurant II/IIs stent graft system

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

Quick links to clinical outcomes sections

Clinical experience overview2

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

Event rates at 30 days across 1,400+ patients

Trials and registries

Trial study design

Technical/
deployment 
success (%)

Type I endoleak (%)

Endurant FIM study3
(N = 81)

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

100

0

Endurant US IDE study (Bifur)4
(N = 150)

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

99.3

0

ENGAGE OUS registry5
(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: 8 years of proven durability with longest-term follow-up of any contemporary EVAR registry6

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)

ENGAGE OUS registry: 5 years of real-world clinical excellence7

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)

The ENGAGE OUS registry through five years: short neck cohort8

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)4,8

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

Procedural performance beyond clinical performance8

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

Back to top

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.

Document thumbnail

Aortic catalog

Choose from a complete portfolio of market-leading aortic vascular therapies to treat aneurysm disease.

Download catalog

Related pages

Request more information

Contact us
*

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).

References

1

Data on file at Medtronic. Data current as of May 2017.

2

Data on file at Medtronic. Data current as of April 2021.

3

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.

4

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.

5

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.

6

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.

7

ENGAGE five-year data. Data on file at Medtronic.

8

Data on file at Medtronic.