Data shows more deaths with Medtronic’s AneuRx: FDA

New data point to greater deaths in patients receiving Medtronic Inc’s AneuRx stent graft system, which treats artery bulges in the abdomen, the Food and Drug Administration said on Tuesday.

“We now calculate, based on the latest information supplied by Medtronic, a mortality rate associated with the initial surgery of 2.3 (percent) instead of the 1.5 (percent) originally calculated for the AneuRx patients,” the FDA said.

The FDA said its results differ from an update provided by the company because the agency looked at a group of patients who were not high risk and received a more flexible version of the stent graft. The agency offered its analysis in a statement dated March 17, but released on Tuesday.

AneuRx is used to treat abdominal aortic Aneurysm, a life threatening condition in which the aortic artery bulges and can burst—often without prior symptoms. About 1.2 million Americans have such a bulge, according to Medtronic, but only 15 percent are diagnosed and half are never treated.

The agency earlier warned of other serious complications in patients receiving the product, including rupture.

Earlier data showed the risk of death in patients who got AneuRx “was significantly greater than in those undergoing open surgical repair,” the FDA said. It has since been working with the company to gather more data.

A Medtronic spokesman could not immediately be reached for comment.

Medtronic shares were up 21 cents, or less than 1 percent, at $47.60 in morning trading on the New York Stock Exchange.