Medtronic AneuRx Stent Graft High Death Rate Prompts FDA WarningMar 18, 2008 | Parker Waichman LLP
Patients receiving Medtronic Inc's AneuRx stent graft system have higher death rates, the Food & Drug Administration (FDA) warned today. Because of the high death rate, the FDA said 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.
Medtronic Inc's AneuRx stent graft system 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.
Medtronic is one of four or five companies that manufacture stent-grafts for the treatment of abdominal aortic aneurysms. Analysts say the market for the devices is worth about $100 million to $150 million, with the cost of each stent-graft in the neighborhood of $12,000 to $14,000.
The FDA said it now calculates the death rate associated with initial surgery for AneuRx patients is 2.3 percent, rather than the 1.5 percent it originally calculated. "These rates are substantially higher than the mortality rate for open surgical repair, which average 0.18 percent per year with a range of 0 percent to 0.3 percent per year," FDA stated in a public health notice dated March 17. "In addition, we now calculate, based on the latest information supplied by Medtronic, a mortality rate associated with the initial surgery of 2.3 percent instead o the 1.5 percent originally calculated for the AneuRx patients."
The AneuRx product was the subject of previous public health advisories from the FDA in 2001 and 2003, after the agency learned of several serious adverse events, including aneurysm ruptures, in patients treated with the Medtronic stent-graft. 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 spokesperson told Reuters that the company's own analysis showed its stent graft performs better compared to open surgery in late AAA-related deaths. The spokesperson also noted that the FDA cited other factors affecting death rates besides the device, including poor follow-up, patients refusing treatment, and an elderly patient population.
The FDA said its results differ from an update provided by Medtronic because the agency looked at a group of patients who were not high risk and received a more flexible version of the AneuRx stent graft.