ENGAGE registry published in European Journal of Vascular and Endovascular Surgery (EJVES)

The 10-year global real-world data for Endurant™ stent graft system are now published in EJVES.1

2023 annual physician clinical update

Endurant™ and Endurant™ II/IIs stent graft system




The Endurant™ family of products has been chosen by physicians to treat more than 500,000 patients worldwide.2

As the first and only endovascular aneurysm repair (EVAR) 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



Clinical experience overview

Trials and registries

Duration (years)

N (total patients: 1,896)

Endurant™ FIM study

1

81

Endurant™ France post-market study

5

180

de novo cohort of ENGAGE PAS (US)

5

178

ENGAGE OUS registry full cohort

5

1,263

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 more than 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: 10 years of evidence with global EVAR registry1

10-year clinical outcomes

%

Freedom from (FF) aneurysm-related mortality (ARM)

97.3%

FF aneurysm-related reinterventions‡,§

71.4%

AAA sac regression

64.1%

Type Ia endoleaks

4.7%

Main body migration

1.3%

ENGAGE OUS registry: five years of real-world clinical excellence5

Clinical outcomes (N = 1,263)

%

FF ARM

97.8%

FF secondary endovascular procedure (overall)

84.3%

AAA sac regression#

61.4% (302/492)

Type Ia endoleaks#

1.6% (8/501)

Main body migration#

0.3% (1/291)

ENGAGE OUS registry: five year short neck cohort6

Cumulative through five 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 Ia 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)4,7

Clinical outcomes

One-year

Five-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)

FF conversion

100%

100%

FF secondary procedure

95.3%

89%

FF ARM

100%

99.2%

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