EU Suspends Endologix’s CE Mark

The European Union suspended the CE Mark of Endologix’s AFX abdominal aortic aneurysm system.

The suspension is due to reports of Type III endoleak complications, such as when blood leaks from grafts following a repair procedure, related to the older version of the AFX system. No reports of endoleaks have been reported with the later-generation AFX2 system, the company said.

Despite the suspension, the device is still available in the U.S., Japan and other international markets. — Cynthia Jessup