FDA approves Aorfix (Lombard Medical) for treatment of Abdominal Aortic Aneurysms

Lombard Medical Technologies PLC, the specialist medical technology company focused on innovative vascular products, announced on 15 February 2013 that Aorfix has been approved for commercial sale in the U.S. by the FDA.

Aorfix is a flexible stent graft for the endovascular repair of Abdominal Aortic Aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix, has demonstrated that Aorfix can successfully treat a larger patient population than competing devices, including both standard and difficult to treat cases of AAAs.

The U.S. approval for Aorfix includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Aorfix is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees. Aorfix has CE Mark approval.