FDA Approves Lombard Medical's Aorflex Delivery System

June 21, 2013—Lombard Medical Technologies PLC (Oxfordshire, UK) announced that the US Food and Drug Administration (FDA) has approved the company's Aorflex delivery system for commercial use in the United States.

According to Lombard Medical, the Aorflex delivery system is the company's next-generation delivery system for its Aorfix stent graft, which was approved by the FDA in February 2013 (along with the previous-generation delivery device) for the endovascular repair of abdominal aortic aneurysms. Aorfix is approved in the United States to treat abdominal aortic aneurysms with neck angulations up to 90º.

Lombard Medical stated that the Aorflex offers clinical benefits over the original delivery system that are aimed at improving the overall ease of use of the Aorfix stent graft. These improved benefits include 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, an x-ray marker to give positional feedback to physicians, and reduced deployment forces.

The company intends to launch Aorfix with Aorflex in the United States in the second half of 2013, and it will conduct a launch event at the Veith Symposium in New York, New York in November 2013. The Aorflex delivery system has been commercially available in Europe since April 2012.