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Medtronic’s Endurant stent graft

This article was originally published in The Gray Sheet

Executive Summary

Endovascular stent graft for repair of abdominal aortic aneurysms will debut in Europe by mid-July following CE mark approval, announced July 7. In the United States, Medtronic anticipates a market launch in three to five years after beginning a clinical trial June 23 to support a planned PMA submission. The study will enroll 150 patients at 30 sites over the next 18 months. The device, which is designed to address aortas that are highly angulated and aneurysms with short necks, will be compared in the study with Medtronic's Talent abdominal stent graft, which was approved by FDA in mid-April ("1The Gray Sheet" April 21, 2008, In Brief). The trial has a primary safety endpoint of no major adverse events within one month of implant and a composite endpoint of successful treatment of aneurysms at one year
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