AneuRx

RSS
Modified on 2009/10/14 21:50 by admin
AneuRx is a synthetic graft device manufactured by Medtronic. AneuRx is used to repair abdominal aortic aneurysms. According to the FDA, as of April 2001 the agency had received reports of approximately 25 aneurysm ruptures, as well as other serious adverse events, in patients who have received AneuRx.

In December 2003, the FDA Center for Devices and Radiological Health issued a Public Health Notification with updated information on the mortality risks associated with the AneuRx Stent Graft System, when implanted for the prevention of Abdominal Aortic Aneurysm rupture. This information was based on an analysis of the extension of an investigational premarket study, which began in March of 1996, with a subgroup of 942 patients, followed through October 24th, 2002. Based on the findings of the study, it was recommended that the AneuRx Stent Graft be used only in patients who meet the appropriate risk-benefit profile and who can be treated in accordance with the instructions for use.

See your doctor if you have received an AneuRx device and you are concerned about its safety. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.



See Also

  1. Aneurysm Grafts: Overview
  2. Aneurysm
  Name Size