FDA Issues Updated Safety Alert on Endologix AAA Repair Grafts

The US Food and Drug Administration (FDA) has issued an update to its January 2022 safety communication on the use of Endologix AFX endovascular grafts to treat patients with abdominal aortic aneurysm (AAA).

The update includes the following new information in the patient labeling for the AFX2 device:

  • An increase in the rate of type III endoleaks was detected with previous iterations of the AFX system.

  • It is uncertain whether the increased rate of type III endoleaks has been addressed by the AFX2 system because the risk of type III endoleaks at 3 years and beyond is not yet established.

In the update, the FDA also said it will require Endologix to conduct a postmarket study to continue to evaluate the benefits and risks of the AFX2, including the risk of type III endoleaks.

The study will compare outcomes in patients treated with AFX2 to those of patients with other commercially available AAA endovascular grafts, using real-world data through 10 years of follow-up.

The FDA continues to recommend that clinicians consider using available alternative treatment options for AAA patients rather than the AFX2 device.

The FDA continues to recommend “at least yearly, lifelong follow-up” to monitor for type III endoleaks in patients who have had their AAA treated with any type of Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2).

The complete updated information on the Endologic AFX endovascular graft system is available on the FDA website.

Problems related to the device should be reported to the FDA’s MedWatch program.

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