CLINICAL OUTCOMES Endurant II Stent Graft Systems

Only the Endurant™ II stent graft system has the deep clinical experience and favorable clinical outcomes designed to treat both challenging and straightforward anatomy. In the past 5 years, the Endurant II stent graft system has been used in 1 of every 2 EVAR cases, with use in more than 280,000 patients worldwide.*

*Data as of May 2017.


CLINICAL EXPERIENCE OVERVIEW*

Trials and Registries Duration
(years)
N
(total patients: 1895)
EU TRIAL 1 80
France Post Approval 3 180
US Post Approval 4 178
ENGAGE Global Registry 5 1263
US IDE AUI Arm 5 44
US IDE Bifurcated Arm 5 150

 Medtronic data on file. Data current as of August 2017.

EVENT RATES AT 30 DAYS ACROSS 1400+ PATIENTS

  Trial Study Design Technical / Deployment 
Success (%)
Type I Endoleak (%)
EU Trial1
(N = 80)
Prospective, open-label, multicenter trial conducted at 10 sites across Europe. 100 0
US IDE2
(N = 150)
Prospective, multicenter trial conducted at 26 sites across the United States.
Reviewed by independent core lab.
99.3 0
ENGAGE Registry3
(N = 1263)
Post-market, real-world registry involving 1263 patients at 79 sites in 30 countries. 99.4 1.2

1 ENDURANT EU trial: Rouwet EV, et al. Eur J Vasc Endovas Surg 2011;42(4):489-497.

2 ENDURANT US IDE trial: Singh MJ, et al. J Vasc Surg 2016;64:55-62.

3 ENGAGE Registry: Stokmans RA, et al. Eur J Vasc Endovas Surg 2012;44:369-375.


Engage Registry Milestone: 5 Years of Real World Clinical Excellence*

Description %
Aneurysm Related Mortality†  FF 97.8%
Secondary Endovascular Procedure†  (overall) FF 84.3%
AAA Sac Diameter Stable or Decrease 89.4%
Type 1a Endoleaks 1.6%
Main Body Migration 0.3%

 

* ENGAGE 5-year data. Data on file at Medtronic.

Data reported through 5-year timeframe.

Data reported at 5-year timeframe.

ENGAGE short neck analysis 5 years (cumulative)

The ENGAGE registry is the largest analysis of short AAA neck patients using a single contemporary EVAR device followed through 5 years.

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%

 

* 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.


RESULTS OF THE ENDURANT US IDE TRIAL1

The Endurant II stent graft closes the outcomes gap between challenging and straightforward anatomies.

  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% (0/132) 0.0% (0/73)
Conversion 0.0% (0/132) 0.0% (0/73)
Secondary Procedure 95.3% FF 89% FF
Aneurysm-related Mortality 100% FF 99.2% FF

 1 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. 2016;64:55-62.

PROCEDURAL PERFORMANCE BEYOND CLINICAL PERFORMANCE

Outcomes from the US IDE Trial

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

 1 Woo E, presentation at Charing Cross 2015. 


pdf Annual Physician Clinical Update (.pdf)

Endurant Stent Graft System Annual Physician Clinical Update

954KB

pdf 5 Yr ENGAGE Gender Analysis Schermerhorn Deck (.pdf)

5 Years Makes A Difference – Endurant Is The Only Stent Graft To Show Comparable Outcomes Between Men and Women At 5 years

1.8MB