FDA cites increasing risks of death seen with Medtronic stent to treat aneurysm

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 who've had the device implanted for five years are increasingly likely to die of an aneurysm. FDA has issued similar alerts before, but the new data show the risks keep climbing years after the stent 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 to prevent bulging of the aorta, which can burst and cause sudden death.

Medtronic said about 1.2 million people in the U.S. are at risk of the aneurysms, though only half are ever treated. About 75,000 patients in the U.S. have its stent, which is an alternative to surgery. Endologix Inc. and Cook Medical make competing products.

FDA estimated 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.

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.

Medtronic spokesman Daniel Beach said the study analyzed by FDA showed 13 deaths out of 931 patients with its device. Eight deaths were in patients 80 years and older.

He added that AneuRx's safety compared with surgery in the days after treatment outweigh the risks it carries years later. According to Beach, the 30-day death rate for patients who undergo surgery is 4.8 percent, compared with the 1.2 percent rate for patients with a stent.

"You're comparing an open-chest surgical procedure to a minimally invasive implantation through the femoral artery, so that accounts for the huge difference in mortality," Beach said.

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

Shares of the Minneapolis-based company rose 95 cents Tuesday to close at $48.34. Endologix shares rose a penny to $3.05.