June 20, 2018

FDA letter updates risks of Type III endoleaks with aortic endovascular graft systems

By: Judy Mathias

Editor’s Note

In a June 19 letter to healthcare providers, the Food & Drug Administration (FDA) says it continues to evaluate information from several sources, including manufacturers, on the risks associated with Type III endoleaks with various endovascular graft systems used for treatment of abdominal aortic aneurysms (AAAs) and aorto-iliac aneurysms.

Based on new information, the FDA says the Endologix AFX with Strata device is at greater risk for Type III endoleaks than other endovascular AAA graft systems.


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