FDA Warns Endologix AFX2 Endovascular AAA Graft Systems Unsafe for Some Uses

The FDA has issued an updated warning against the use of Endologix’s AFX2 endovascular graft system for routine treatment of abdominal aortic aneurysms (AAAs) due to the risk of endoleaks –blood leaking into the aneurysm sac after the stent graft is in place.

The FDA is now recommending that healthcare providers consider using available alternative treatment options. The recommendation followed a November 2021 opinion of an expert panel of the agency’s Medical Devices Advisory Committee, which supported continued availability of the device for select populations “in situations when alternative treatment options are insufficient or not available.”

The agency said it is working with Endologix to identify patients who may benefit from treatment with the AFX2 device, updating labeling and gathering long-term safety data.