FDA recommends not using AAA stent graft system due to type III endoleaks
The FDA issued an alert recommending operators not routinely use a stent graft system for treatment of patients with abdominal aortic aneurysms because of risk for type III endoleaks.
As Healio previously reported, the FDA’s Circulatory System Devices Panel in November advised that the stent graft system (AFX2, Endologix) not be used for routine AAA treatment but that its benefits may outweigh its risks in certain niche and no-other-option populations.
In the alert, the FDA agreed with the panel recommendation. “Based on the FDA’s analysis and advisory committee input, the FDA recommends health care providers consider using available alternative treatment options for AAA patients rather than the AFX2 device,” the agency wrote.
The FDA will work with the manufacturer to identify patients who may benefit from the device despite the risks, to update the device’s labeling and to collect additional data to assess long-term safety issues, according to the alert.
The agency recommended that patients treated with any model of the AFX system be followed up at least yearly by a health care professional and that patients discuss treatment options with their physician before undergoing an AAA procedure.