Aorfix aneurysm graft CE mark expected soon
This article was originally published in Clinica
Executive Summary
Lombard Medical Technologies hopes to gain expanded CE mark approval for Aorfix, its endovascular stent graft, in the first half of 2009. The expanded indication will enable the device, which treats abdominal aortic aneurysms (AAAs), to be used in patients with high-angle-neck aneurysms. The Didcot, UK company expects that the use of Aorfix to treat patients with aneurysm neck-angulations of up to 90 degrees will accelerate sales in Europe. Lombard is also concentrating on the US market, with patient recruitment into a pivotal US trial of Aorfix due in the second quarter of 2009; over 70% of the trial's intended 160 patients have so far been enrolled.