FDA Approves Aorflex Delivery System

Lombard Medical Technologies PLC officials announce that the Food and Drug Administration have approved the Aorflex delivery system for commercial use in the United States. The Aorflex delivery system is the company’s next-generation delivery system for its Aorfix stent graft, which was recently approved by the FDA in February 2013 (along with the previous generation delivery device) for the endovascular repair of abdominal aortic aneurysms (AAAs). Aorfix is the only device licensed in the US to treat AAAs with neck angulations up to 90°, a key advantage over other currently available stent grafts. The company intends to launch Aorfix with Aorflex in the United States in the second half of 2013.

The Aorflex delivery system has been commercially available in Europe since April 2012 and has received positive feedback from clinicians. Aorflex offers a range of clinical benefits over the original delivery system aimed at improving the overall ease of use of the Aorfix stent graft, including:

• Smoother introduction of the delivery system into blood vessels through the use of a hydrophilic coating
• Greater deployment control with exceptional one-to-one torque
• X-ray marker to give positional feedback to physicians
• Reduced deployment forces.