Healthcare Professionals
Endurant II
AAA Stent Graft System
Clinical Confidence
Summary
| ENDURANT U.S. CLINICAL DATA | 12 MONTHS |
|---|---|
| Type I endoleak | 0% (0/130) |
| Migration | 0% (0/134) |
| Aneurysm sac diameter: decrease or stable | 100% (136/136) |
| Conversion to surgery | 0% (0/141) |
| Aneurysm-related mortality (ARM) | 0% (0/141) |
| Post-operative rupture | 0% (0/141) |
US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608 |
|
| ENDURANT TEST GROUP | |
| Technical Success1 | 99.3% (149/150 patients) |
1Defined as the successful delivery and deployment of the stent graft |
|
| 30 DAYS | |
| Freedom from Major Adverse Events2 | 96.0% |
2Major Adverse Events defined as: All Cause Bowel Ischemia, Myocardial Infarction, Paraplegia, Procedural Blood Loss ≥1000 cc, Renal Failure, Respiratory Failure, Stroke |
|
| CONSISTENTLY COMPELLING RESULTS AT 2 YEARS US IDE CLINICAL OUTCOMES AT 2 YEARS* |
|
|---|---|
| Type I endoleak | 0% (0/122) |
| Migration | 0% (0/105) |
| Aneurysm sac diameter: decrease or stable | 98.3% (114/116) |
| Conversion to surgery | 0% (0/141) |
| Aneurysm-related mortality (ARM) | 0% (0/144) |
| Post-operative rupture | 0% (0/141) |
| Secondary endovascular procedures | 1.4% (2/141) |
| 2-year data Data source: 2011 Endurant Clinical Update | |
