FDA Safety Communication: Type III Endoleaks risks with Endologix AFX Endovascular AAA Graft Systems use
The U.S. Food and Drug Administration (FDA) issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from the November 2021 meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee.
In addition, the FDA is providing new recommendations to healthcare providers who treat patients with abdominal aortic aneurysms (AAA) using the Endologix AFX2 device, the currently available AFX product.
Based on the available data and advisory committee input, the FDA recommends that healthcare providers consider using available alternative treatment options for AAA patients rather than the AFX2 device. The FDA emphasizes the importance of at least yearly, lifelong follow-up with a healthcare provider for all patients who have had their AAA treated with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) to monitor for Type III endoleaks.
This safety communication provides:
- Recommendations for patients with AAA treated with any AFX endovascular graft or considering treatment with AFX2.
- Recommendations for healthcare providers who treat and follow patients with AAA.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with Endologix AFX Endovascular AAA Graft Systems to the FDA.
