Lombard Medical Announces First-in-Man Procedure with IntelliFlex LP Delivery System for Aorfix Stent Graft

November 12, 2015—Lombard Medical, Inc. announced the successful outcome of the first-in-man clinical case using its new IntelliFlex LP low-profile delivery system to deploy the company’s Aorfix endovascular stent graft for the endovascular repair of abdominal aortic aneurysms.

According to Lombard Medical, the IntelliFlex LP delivery system features a low-profile, intuitive, compact, and ergonomic design that enhances the precision and control of Aorfix deployment and placement. The system incorporates an integrated exchange sheath designed to reduce the possibility of vessel trauma during the procedure.

The first IntelliFlex LP case was performed by Prof. Andrew Holden, MD, and Andrew Hill, MD, at Auckland City Hospital in Auckland, New Zealand. Prof. Holden is Director of Interventional Services and Associate Professor of Radiology at Auckland University School of Medicine. Dr. Hill is Professor of Surgery at University of Auckland.

Prof. Holden is scheduled to present a video of the first case at the VEITHsymposium, which will be held November 17–21, in New York, New York.

In the company’s announcement, Prof. Holden commented, “The new IntelliFlex delivery system was extremely straightforward and a real pleasure to use. I particularly appreciated the new Y-mechanism that enables greater control and precision when deploying the graft. This is a significant advancement for the Aorfix system and the device can now be used even more reliably in both routine and challenging anatomies.”

Dr. Hill added, “The new Aorfix delivery system has great top end control allowing for very accurate placement of the device. Further, the integrated exchange sheath was really beneficial and the hemostatic valve copes extremely well with multiple passages.”

The company plans to file for US Food and Drug Administration (FDA) approval for the IntelliFlex LP delivery system in early December and launch the device in the United States in the second quarter of 2016. European approval and launch is anticipated in the third quarter of 2016.

The Aorfix received FDA approval in 2013, and is commercially available in the United States, United Kingdom, Germany, Spain, Italy, Austria, Switzerland, the Czech Republic, Russia, Greece, Canada, Mexico, Brazil, Japan, Hong Kong, Poland, New Zealand, Argentina, Sweden, Colombia, Ireland, Chile, Peru, and Uruguay.