Endurant™ and Endurant™ II/IIs stent graft system
The Endurant™ family of products have been chosen by physicians to treat more than half a million patients worldwide.1
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
Choose the standard of EVAR durability.
| 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 full cohort | 5 | 1263 |
| ENGAGE OUS registry extended cohort | 10 | 390 |
| Endurant™ US IDE study (AUI) | 5 | 44 |
| Endurant™ US IDE study (bifur) | 5 | 150 |
| 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 |
| 10-year clinical outcomes | % |
|---|---|
| Freedom from (FF) aneurysm-related mortality (ARM)‡ | 94.7% |
| FF aneurysm-related reinterventions§,◊ | 70.3% |
| AAA sac regression¶ | 64.1% (107/167) |
| Type la endoleaks¶ | 4.7% (8/172) |
| Main body migration¶ | 1.3% (1/77) |
| 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 |
† Delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site. Deployment success = successful deployment of the device in the intended site and the successful removal of the delivery system.
‡ Data reported through ten-year time frame with full +extended cohort, determined by Clinical Event Committee.
§ Data reported through ten-year time frame with full +extended cohort.
◊ Aneurysm-related re-interventions are defined as all the secondary endovascular procedures (scheduled and unscheduled), secondary vascular procedures and conversions to open repair.
¶ Data reported at 10-year time frame with extended cohort.
# 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 percent based on Kaplan-Meier method.
†† Numbers are freedom from (FF) event survival estimate percent based on interval-censored method.
‡‡ (p < 0.05).
