Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleaks – FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes information about new labeling and a required postmarket study for the AFX2 Endovascular AAA System (AFX2) to better inform patients and health care providers of the risk of Type III endoleaks.

The FDA continues to recommend health care providers consider using available alternative treatment options for patients with abdominal aortic aneurysm (AAA) rather than the AFX2 device. In addition, the FDA continues to emphasize the importance for all patients who had their AAA treated with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) to have at least yearly, lifelong follow-up with a health care provider to monitor for Type III endoleaks.

This safety communication provides:

• Recommendations for patients with AAA treated with any AFX endovascular graft or considering treatment with AFX2.
• Recommendations for health care providers who treat and follow patients with AAA.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with Endologix AFX Endovascular AAA Graft Systems to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE)