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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