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 Trial1 |
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.