FDA 2021 Meeting Will Focus on Postmarket Surveillance Strategies for EVAR Grafts and Endoleak Risks for Endologix AFX Grafts

December 17, 2020—The FDA announced it will convene an Advisory Committee meeting of the Circulatory System Devices Panel in 2021 to discuss the type III endoleak risk for AFX endovascular grafts (Endologix), the type III endoleak treatment options for patients who are implanted with AFX devices, and future postmarket surveillance strategies for all endovascular grafts used for the treatment of abdominal aortic aneurysms. Further details concerning the agenda, timing, and location of the Advisory Committee meeting will be announced in the first quarter of 2021.

In its announcement, the FDA also stated that it is updating the October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2) to provide new data and review current recommendations. At that time, Endovascular Today reported both the FDA communication and Endologix’s response to it.

The FDA advised that the recommendations from the October 2019 safety communication have not changed. The FDA is reminding patients and health care providers of the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) in order to monitor for type III endoleaks.

The FDA further stated that it continues to evaluate new information that suggests the risk of type III endoleaks occurring with the use of AFX endovascular grafts with Duraply graft material (AFX with Duraply or AFX2) may be higher than expected. Because of ongoing concerns regarding this issue, the FDA is committed to obtaining additional postmarket data to better understand the risk of type III endoleaks for AFX endovascular grafts.