FDA Issues Updated Safety Alert for Endologix AAA Repair Grafts


The US Food and Drug Administration (FDA) is reminding clinicians about the need for “at least yearly, lifelong follow-up” to monitor for type III endoleaks in patients with any type of Endologix AFX endovascular graft, including AFX with Strata, AFX with Duraply, or AFX2.

In an updated safety communication released today, the FDA said data from ongoing investigations continue to suggest that there may be a “higher than expected” risk for type III endoleaks when these grafts are used to repair abdominal aortic aneurysms (AAA).

As previously reported by Medscape Medical News, the FDA issued prior safety alerts regarding the potential for endoleaks with the Endologix AFX endovascular grafts in June 2018 and again in October 2019.

The recommendations for addressing this issue have not changed, the FDA said today. They include:

  • Discuss the benefits and risks of all available AAA treatment options with patients.

  • Consider the benefit-risk profile of AFX endovascular grafts compared with alternative treatment options for each individual patient.

  • When making AAA treatment recommendations, and as part of the informed consent process, consider that data suggest there may be a higher than expected risk of type III endoleaks with any Endologix AFX endovascular graft.

  • Read and carefully follow the Endologix AFX endovascular AAA system instructions for use, which were revised in 2018 to include updated information about type III endoleaks.

  • Closely monitor patients who have any AFX endovascular graft implanted and ensure yearly imaging follow-up at a minimum to monitor for endoleaks and aneurysm expansion.

Due to the “ongoing concerns” regarding this issue, the FDA pledged to collect additional postmarket data to better understand the risk of type III endoleaks for AFX endovascular grafts.

The FDA will also hold an advisory committee meeting in 2021 to discuss the risks and treatment options for AFX endovascular grafts, as well as future postmarket surveillance strategies for all endovascular grafts used for the treatment of AAA.

Further details about the meeting will be announced in the first quarter of 2021.

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