The FDA has approved Lombard Medical Technologies' Aorfix, a stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs), for commercial sale in the U.S.
The agency based its decision on data from the U.S. PYTHAGORAS prospective, controlled trial, which included 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, according to the London-based company. In Europe, Aorfix is already licensed to treat neck angulations of
up to 90 degrees.
The PYTHAGORAS trial included 218 patients at risk of aneurysm rupture; 151 patients with neck angles greater than 60 degrees and 67 patients with neck angles less than 60 degrees.