WASHINGTON (Reuters) - New data point to greater deaths in patients receiving Medtronic Inc’s AneuRx stent graft system, which treats artery bulges in the abdomen, the U.S. 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.
AneuRx is used to treat abdominal aortic aneurysm or AAA, 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. AneuRx is part of Medtronic’s smallest of four cardiovascular units, according to Medtronic spokesman Daniel Beach.
Beach, in an e-mail to Reuters, said the company’s own analysis showed its stent graft “performs better compared to open surgery in late AAA-related deaths.”
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.
Beach added the deaths cited by the FDA were 13 out of 931 patients the agency studied. Other factors affecting death rates besides the device, including “poor follow-up, patients refusing treatment, and an elderly patient population,” he added.
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.
AneuRx should only be used following its instructions and in patients who are willing to complete follow up care and at less of a risk for surgery, the FDA added. Surgeon experience also matters, the agency added.
Medtronic shares rose 36 cents, or 0.76 percent, to $47.75 on the New York Stock Exchange shortly after midday.
Reporting by Susan Heavey, editing by Maureen Bavdek, Richard Chang