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Aorfix earns FDA approval

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Lombard Medical Technologies today announced FDA approval of Aorfix, its flexible stent graft for the endovascular repair of abdominal aortic aneurysms.

The approval includes a label indication for treatment of patients with angulations at the neck of the aneurysm from 0 to 90°, making Aorfix the only endovascular stent graft licensed in the United States for use in cases with neck angulations greater than 60°, according to a press release issued by the manufacturer.

The US PYTHAGORAS trial of Aorfix indicated that the stent graft can successfully treat a larger patient population when compared with other devices, including standard cases of abdominal aortic aneurysms and those that are more difficult to treat. PYTHAGORAS enrolled 218 patients at risk for aneurysm rupture, including 151 patients with neck angles greater than 60° and 67 patients with neck angles less than 60°. Data showed no aneurysms expanded in patients with neck angles less than 60° and 1.8% expanded in patients with high neck angles, the release stated.

The stent graft is already approved to treat neck angulations of up to 90° in Europe.