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

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Clinical Experience Overview2

Trials and Registries Duration
(years)		 N
(total patients: 1896)

Endurant FIM Study

 1 81

Endurant France Post-market Study

 5 180

de novo cohort of ENGAGE PAS (US)

 5 178

ENGAGE OUS Registry

 5 1263

Endurant US IDE Study (AUI)

 5 44

Endurant US IDE Study (Bifur)

 5 150

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Event Rates at 30 Days Across 1400+ 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 = 1263)

Post-market, real-world registry involving 1263 patients at 79 sites in 30 countries.

99.0

1.2

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Engage OUS Registry Milestone: 5 Years of Real-world Clinical Excellence6

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)

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The ENGAGE OUS Registry Through Five Years7

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%

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Results of the Endurant US IDE Study (Bifur)4,7

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

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Procedural Performance Beyond Clinical Performance7

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

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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

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*

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).

Core lab determined.

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

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

7

Data on file at Medtronic.