FDA Warns Of High Mortality Rate For Medtronic Stent

Law360 (March 19, 2008, 12:00 AM EDT) -- Patients using Medtronic Inc.'s AneuRx stent graft system have a higher mortality rate than previously thought, the U.S. Food and Drug Administration announced this week.

In a statement posted on its Web site, the FDA wrote that the per-year mortality risk in patients receiving the stent continues to increase for years after the device is implanted.

The mortality rate is also significantly higher for patients who have the stent than for patients who have surgery, the FDA said.

Earlier research had suggested that aneurysm-related mortality was...
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