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The Food and Drug Administration (FDA) today updated information to the medical community about the risk of mortality associated with use of the AneuRx Stent Graft System. The system is implanted in patients to prevent rupture of abdominal aortic aneurysms (AAA).
These devices remain safe and effective. The purpose of the notification is to provide additional information to physicians so they can make a more informed decision about using the product to treat their patients.
FDA originally approved these devices in 1999 based on clinical studies conducted by the manufacturer which began in 1996. The agency has continued to monitor the devices since they came on the market and has provided a number of reports to the medical community to supplement other scientific reports.
Since the previous public health notice in April 2001, FDA has worked with the manufacturer, Medtronic AVE, as well as other sources, to obtain more complete follow-up data on a group of study patients who received the flexible model of the AneuRx Stent Graft.
The information in today’s notification is based on an FDA analysis of follow-up data for 942 patients enrolled in Medtronic’s pre-market clinical trial. The analysis estimated that there was 2.7% mortality three years after the patients in this group were implanted with the device. The risk of aneurysm-related death beyond three years appears to be at least 0.4% per year, but it is difficult to accurately estimate this because of the small number of patients so far followed for more than three years.
The notification emphasizes the importance of following the manufacturer's instruction regarding careful selection and follow-up monitoring of patients. The notification also provides several factors that physicians should consider in determining the risk-benefit profile and the appropriate treatment for a patient with AAA.
Details of FDA’s analysis, along with a discussion and recommendations to physicians, are reported in the Public Health Notification: Updated Data on Mortality Associated with Medtronic AVE AneuRx Stent Graft System. The notification is available at: http://www.fda.gov/cdrh/safety/aneurx.html.
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