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December 20, 2010
FDA Approves Medtronic's Endurant Stent Graft for EVAR
December 21, 2010—Medtronic, Inc. (Minneapolis, MN) announced that the US Food and Drug Administration approved the company's Endurant stent graft system for the endovascular repair of abdominal aortic aneurysms.
As reported by Endovascular Today, Medtronic's 1-year patient follow-up data in the United States pivotal study of the device were presented at the VEITH Symposium in New York City on November 10. The study included 150 patients at 26 medical centers and successfully met its primary goals and endpoints for assessing the safety and effectiveness of the Endurant stent graft. Medtronic noted that the study demonstrated no postimplant aneurysm ruptures or aneurysm-related deaths through 1 year of patient follow-up, and no patients experienced enlargement of their aneurysms during this time frame. Also, there were no device migrations or device-related endoleaks through 1 year. Michel Makaroun, MD, is the principal investigator for the clinical study.
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