The US Food and Drug Administration (FDA) has issued a new safety communication on the risk of Type III endoleaks with use of the Endologix AFX endovascular graft systems for the treatment of abdominal aortic aneurysms (AAA).
The safety communication, published on the FDA website on 28 October, stated: “The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm [Type III endoleak] when Endologix AFX endovascular grafts [AFX with Strata, AFX with Duraply, or AFX2] are used for the treatment of [AAA].”
The communication continues that the FDA had previously communicated about the greater risk of Type III endoleaks occurring with the Endologix AFX with Strata device compared to other endovascular graft systems, which can result in serious injury.
“It is important for patients and health care providers to be aware that data from an integrated healthcare system, published in a recent conference abstract, suggest there also may be a higher than expected risk of Type III endoleaks occurring with the use of AFX with Duraply and AFX2 endovascular grafts.”
The safety communication details a number of “important recommendations” for patients who have or are considering an Endologix graft system for the treatment of AAA, including: “Be aware that recent data suggest there may be a higher than expected risk of blood continuing to leak into the AAA [Type III endoleak] which can result in serious injury, including death when any AFX endovascular graft is used for the treatment of AAA. As a result the FDA recommends at least yearly, lifelong follow-up for all patients who have had their AAA treated with any AFX endovascular graft system.”