After lengthy discussions on 2 November, the US Food and Drug Administration’s Circulatory System Devices Panel concluded that AFX graft stents from Endologix, Inc. to treat abdominal aortic aneurysms (AAA) should be reserved for a select group of patients, and not for routine use.
The Endologix system treats patients with AAAs through endovascular grafting, which is a less invasive technique to repair an aneurysm...