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...