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(AP) - Patients treated with a Medtronic stent to
prevent aneurysms appear more likely to die than those who undergo surgery, the Food and Drug Administration said Tuesday.

      The FDA said new data on the company's AneuRx stent showed
patients with the device were increasingly likely to die of an
aneurysm. FDA issued similar alerts in 2001 and 2003, but the
agency said the new data shows risks continue rising five years
after the device is implanted.

      The small, mesh-wire tube is inserted into the abdominal aorta,
a vessel that provides blood to the lower body. The stent is
designed as an alternative to surgery, which is often necessary to
treat dangerous bulges of the aorta. 

However, FDA said in rare
cases the device appears to raise the risk of fatal events.

      FDA estimated that 1.5 percent of patients who've had the device
five years will die from an aneurysm, well above the 0.18 percent
death rate in patients undergoing surgery.

      The agency said the stents' risks vary greatly depending on the
age and health of the patient. 

For a 70-year-old patient in good
health, FDA said the risk of death is only 2 percent, but for
someone with multiple health problems, such as heart or lung
damage, the risk could be as great as 40 percent.

      FDA recommended Tuesday that doctors only use AneuRx according
to its labeling. Doctors sometimes use stents off-label, or outside
of FDA-approved uses, in other types of blood vessels.

      Medtronic did not immediately return calls for comment.

      Shares of the Minneapolis-based company rose 55 cents Tuesday to
$47.94 in afternoon trading.

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Health

Patients treated with a Medtronic stent to
prevent aneurysms appear more likely to die than those who undergo surgery, the Food and Drug Administration said Tuesday.

FDA says Medtronic stent riskier than surgery for aneurysms

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