Ancure Endograft System and AneuRx Stent Graft System
Audience: Vascular Surgeons, Hospital operating room personnel
The FDA Center for Devices and Radiological Health (CDRH) has issued a public health notification regarding serious problems that have occurred with these two endovascular prosthetic graft devices, used to treat infrarenal Abdominal Aortic Aneurysm (AAA). The Notification letter provides a brief background on endovascular repair of AAA, lists the specific problems that occurred with the devices, and makes recommendations concerning their continued use.
[April 30, 2001 - Public Health Notification - FDA]