Clinical Outcomes
Safety and effectiveness of the Endurant AAA Stent Graft System
Summary
| ENDURANT U.S. PMA CLINICAL DATA | 12 MONTHS |
|---|---|
| Freedom from anuerysm mortality | 100% |
| Aneurysm rupture | 0.8% (1/133 patients) |
| Conversion to surgery | 0.0% (0/133 patients) |
| Stent graft migration | 0.0% (0/125 patients) |
| Type I | 0.0% (0/123 patients) |
| Type II | 8.9% (11/123 patients) |
| Type III | 0.0% (0/123 patients) |
| Type IV | 0.0% (0/123 patients) |
| Anchoring pin fracture | 0.0% (0/129 patients) |
| Stent graft kinking/twisting | 0.8% (1/129 patients) |
| Stent graft wireform fracture | 0.0% (0/129 patients) |
| Suprarenal bare stent fracture | 0.0% (0/129 patients) |
| 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 | |
Last updated: 24 Jan 2012