Lombard files final FDA clinical module for Aorfix stent graft

Lombard Medical Technologies has registered the final clinical module with the US Food and Drug Administration (FDA) for its Aorfix stent graft.

The Aorfix is an endovascular stent graft designed to treat complex tortuous anatomy which is associated in advanced abdominal aortic aneurysm (AAA) disease.

The company said Aorfix’s pivotal clinical trial is ongoing in the US.

Lombard Medical has now filed all six pre-market approval (PMA) modules required for its FDA submission and three of these have been approved by the FDA.