FDA Links Increased Risk of Death to Medtronic Stent
The Food and Drug Administration reported recently new data on Medtronic’s AneuRx stent. The new data showed patients treated with the Medtronic stent to prevent aneurysms appear more likely to die than those who undergo surgery. It further describes that those who had the device implanted for five years are at an increased risk of death by aneurysms. The FDA have reported similar risks in the past, but the new data show the risks continue to climb each year after the stent is implanted. Medtronic said about 75,000 patients in the U.S. have its AneuRx stent as an alternative to surgery. The FDA estimates that 1.5 percent of patients who've had AneuRx five years will die from an aneurysm, well above the 0.18 percent death rate in patients who had surgery. FDA recommended that doctors use AneuRx only for what its label prescribes. Doctors sometimes use stents outside of FDA approved uses.
