Medtronic has introduced the Endurant II AAA Stent Graft system in the US, following the US Food and Drug Administration's (FDA) approval.
The Endurant II AAA Stent Graft system is designed for the treatment of abdominal aortic aneurysms through endovascular repair (EVAR).
The new system features new lower-profile delivery system, with extended hydrophilic coating, which allows the 28mm-diameter bifurcated segment to fit inside an 18 French outer diameter catheter.
The radiopacity of the distal end of the bifurcated segment’s contralateral gate has been improved to enhance visibility and aid with limb insertion, placement and deployment.
The system also comprises two new contralateral limb lengths (156mm and 199mm) which provide more options in sizing and can reduce the number of pieces required for an EVAR case.
The FDA approval was based on the results of the US clinical study of the predicate device, which demonstrated no Type I endoleaks, migration, conversion to surgery, or aneurysm-related mortality.
Furthermore, aneurysm sac diameter decreased or remained stable in 98.3% of patients at two years.
Endurant II AAA Stent Graft has also received CE mark approval in December 2011.