FDA Provides an Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems

Today, the FDA issued a safety communication providing new information about the risk of blood continuing to leak into an aneurysm (Type III endoleak) when Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply, or AFX2) are used for the treatment of abdominal aortic aneurysm (AAA). As we continue to evaluate data from an integrated healthcare system, as published in a recent conference abstract, we are emphasizing the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft in order to monitor for Type III endoleaks.

Read the Safety Communication