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FDA notes Medtronic device deaths

Wall Street Journal (subscription required), March 20, 2008
The Food and Drug Administration said it saw a higher death rate after five years among patients treated for abdominal aortic aneurysms with Medtronic Inc.'s AneuRx stent-graft system than among those treated through conventional surgery. The FDA said it was focusing on the AneuRx stent-graft system because it is the only currently marketed device that has a significant number of patients who have been followed for at least five years after receiving a device.