Update: Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular Graft Systems
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind 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 continues to evaluate new information which 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. In addition, the FDA will convene an Advisory Committee meeting in 2021 to discuss the Type III endoleak risk and treatment options for AFX endovascular grafts, and future postmarket surveillance strategies for all endovascular grafts used for the treatment of abdominal aortic aneurysms (AAA). Further details about the meeting will be announced in the first quarter of 2021.
This safety communication provides:
- Important recommendations for people with abdominal aortic aneurysm and their caregivers
- Recommendations for health care providers
- Background on the issue and the FDA’s actions to address the issue
- Instructions for reporting problems to the FDA.
Questions?
If you have questions, contact the Division of Industry and Consumer Education (DICE)..
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