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New Warning Label Added To AFX2 Endovascular Graft

 
• By Elizabeth Orr

The US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.

(Alamy Stock Photo)

Labeling for Endologix, Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system will now carry a warning notifying patients and clinicians that other devices in the product line have been associated with increased adverse event risks, the US Food and Drug Administration announced on 6 December.

Previous AFX devices have been linked to an increased risk of type III endoleaks, in which the graft doesn’t completely separate the aneurysm from the flow of blood in the abdominal artery. When this happens, there’s a higher chance that the aneurysm will rupture and kill or severely injure the patient. The FDA’s scrutiny of this issue dates back to 2017 and has included numerous warnings, physician communications, and meetings

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