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% |
| Procedure Duration (minutes) |
101.5 |
| General Anesthesia |
83.3% |
| Blood Loss (mL) |
185.8 |
| ICU Stay (hours) |
6.2 |
| Hospital Stay (days) |
2.1 |
1 Woo E, presentation at Charing Cross 2015.
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
