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U.S. Department of Health and Human Services

Safety

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AneuRx Stent Graft System

Audience: Interventional Radiologists, Cardiovascular healthcare professionals and Risk Managers

The FDA Center for Devices and Radiological Health issued a Public Health Notification with updated information on the mortality risks associated with the AneuRx Stent Graft System, when implanted for the prevention of abdominal aortic aneurysm rupture. This information was based on an analysis of the extension of an investigational premarket study, which began in March of 1996, with a subgroup of 942 patients followed through October 24th, 2002. Based on the findings of the study, it was recommended that the AneuRx Stent Graft be used only in patients who meet the appropriate risk-benefit profile and who can be treated in accordance with the instructions for use.

[December 17, 2003 - Public Health Notification - FDA]

Previous MedWatch alerts:
[April 30, 2001 - Letter - FDA]