Medtronic has introduced the Endurant II AAA stent graft system in the US, following approval from the Food and Drug Administration (FDA).
The Endurant II AAA stent graft system is used for the minimally invasive treatment of abdominal aortic aneurysms through endovascular repair (EVAR).
The new device features a lower profile delivery system with an extended hydrophilic coating, which allows a 28mm-diameter stent graft to fit inside an 18-French outer diameter catheter.
The system provides options in sizing and can reduce the number of pieces required for an EVAR case, with two new contralateral limb lengths of 156mm and 199mm.
The new graft system facilitates improved radiopacity of the contralateral gate on the distal end, which helps in limb insertion, placement and deployment.
The FDA approval is based on the results from the US clinical study of the predicate device, which showed no Type I endoleaks, migration, conversion to surgery, or aneurysm-related mortality.
Professor and chief of vascular surgery and endovascular therapy at the University of Alabama and one of the principal investigators for the US clinical study of the predicate device, William Jordan, said the Endurant II stent graft enhances the ability to treat more patients than previous devices and to traverse challenging anatomies, especially iliac arteries with tight access.
"Considering the exceptional clinical performance of the original system, the Endurant II stent graft is even easier to use in both straightforward and challenging anatomies," Jordan added.
The Endurant II AAA stent graft also received CE Mark approval in December 2011.
An abdominal aortic aneurysm (AAA) is a condition in which the aorta bulges or weakens, often with no apparent symptoms.
Image: The world headquarters of Medtronic in Minnesota, US. Photo courtesy of: Bobak Ha'Eri.