Updated Safety Info on Endologix Grafts

FDA has updated its 12/2020 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. The update includes an information summary from the agnecy’s 11/2021 advisory committee meeting and new recommendations to health care providers who use the currently available AFX product for treating AAA.

The CDRH Circulatory System Devices Panel meeting recommended that the AFX2 not be used for routine AAA treatment, according to the latest update. “Most committee members supported continued availability of the device for select populations, to be identified based on additional data collection and evaluation, and in situations when alternative treatment options are insufficient or not available,” it says. “Based on the FDA’s analysis and advisory committee input, the FDA recommends health care providers consider using available alternative treatment options for AAA patients rather than the AFX2 device.”