FDA Amends Labeling on Endologix Endovascular Graft Systems

The FDA has approved new safety labeling for Endologix’s AFX2 endovascular graft systems, which is used to treat patients with abdominal aortic aneurysm (AAA).

The labeling changes note that an increased rate of Type III endoleaks was detected with previous iterations of the AFX System and that “It is uncertain whether the increased rate of Type III endoleaks has been addressed by the AFX2 System because the risk of Type III endoleaks at 3 years and beyond is not yet established.”

Type III endoleaks occur when blood flows or leaks either between the graft segments or through holes in the graft material. Endoloeaks are life-threatening and require immediate attention. 

The FDA is requiring Endologix to conduct a postmarket study to evaluate the risks and benefits of the AFX2 device. The study will compare patients with the AFX2 grafts to patients with other commercially available AAA endovascular grafts through 10 years of follow-up.