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# FDA Updates Endologix Endovascular Graft Safety
- URL: https://www.fdaweb.com/fda-updates-endologix-endovascular-graft-safety/
- Published: 2022-12-06T12:00:00.000Z
- Updated: 2026-09-14T18:08:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153333

FDA is updating a [January safety communication](https://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety?ref=fdaweb.com) about the use of Endologix AFX endovascular grafts for treating patients with an abdominal aortic aneurysm (AAA) based on new labeling approved for the currently available product, the AFX2 Endovascular AAA System (AFX2), that includes information to better describe the risk of Type III endoleaks.

FDA also is requiring Endologix to conduct a postmarket study to continue to evaluate the benefits and risks of the AFX2, including the risk of endoleaks. “The study will compare outcomes for patients implanted with AFX2 to patients with other commercially available AAA endovascular grafts, using real world data through 10 years of follow-up,” an FDA notice says.

Additionally, FDA continues to emphasize the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft to monitor for endoleaks.