FDA Warns of More Endologix Graft Risks

The FDA said it’s reviewing new information about potential risks involving Endologix’s AFX endovascular grafts (AFX with Strata, AFX with Duraply or AFX2).

The devices pose a greater risk of Type III endoleaks — when blood continues to leak into an aneurysm — and can result in serious injury, the agency said. It previously announced that a greater risk existed in Endologix’s AFX with Strata device, and has now included the two other devices.

While the agency continues its inquiry, it is stressing the importance of at least yearly, lifelong follow-up for all patients using Endologix’s AFX endovascular grafts.