Medtronic death rates snag FDA’s attention

03/23/08

There may be a higher death rate after five years among patients treated for abdominal aortic aneurysms with a Medtronic Inc. device than among those treated through conventional surgical means, according the U.S. Food and Drug Administration.

A public-health notification posted on the FDA’s Web site said the agency was looking at Medtronic’s AneuRx stent-graft system because it is the only currently marketed device that has a significant number of patients who have been examined for at least five years after receiving a device.

The device is generally inserted through an artery in the leg in order to prevent bulging blood vessels in the abdomen from rupturing, which can be fatal.

Source: Jennifer Corbett-Dooren, The Wall Street Journal, “FDA Notes Medtronic Device Deaths,” March 19, 2008.

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