Medtronic's AAA graft system gets FDA nod

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The FDA has approved Medtronic’s Endurant abdominal aortic aneurysm (AAA) stent graft system, used to treat AAAs of certain sizes (above 5.5 cm in diameter).

The Endurant system is equipped with a wire frame stent that is sewn onto a fabric tube graft, to facilitate blood flow to the aorta and reduce the pressure on the aneurysm and the risk of rupture, said Minneapolis-based Medtronic.

The device is deployed into the groin and facilitates an endovascular approach to aortic repair, and expands at the site of the aneurysm. The company said it does not require removal of the aneurismal segment, like during the open surgical repair method.

In November, researchers from the University of Pittsburgh School of Medicine presented the results of a trial that evaluated the efficacy and safety of the Endurant system, which showed that the deployment was successful in 99.3 percent of the procedures performed by the then investigational device. Only one rupture occurred during the study and the mean hospital stay was 2.1 days.