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Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel

Company’s latest design fails to convince panel leakage issues have been fixed

 
• By Brian Bossetta

The US agency’s Circulatory System Devices Panel found type III endoleaks are still a problem for abdominal aortic aneurysm patients treated with the newest Endologix stent graft, though for some the benefits still outweigh the risks. The panel advised that all patients, however, should continue getting annual screenings.

Entrance to FDA headquarters in Maryland
• Source: Alamy

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...

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