CE Mark Granted for Lombard Medical's IntelliFlex LP Delivery System for the Aorfix EVAR Device

June 21, 2016—Lombard Medical, Inc. announced that it has received CE Mark approval for its IntelliFlex low-profile (LP) delivery system for the Aorfix stent graft for endovascular repair of abdominal aortic aneurysms (AAA). The Aorfix AAA stent graft has global approval to treat aortic neck angulation up to 90º. The company plans to begin shipments to its direct markets in the United Kingdom and Germany in July, with a full commercial launch in the other European markets later in the year.

According to the company, the IntelliFlex LP delivery system features a low-profile intuitive, compact, and ergonomic design for precise control of Aorfix deployment and placement. The system also incorporates an integrated exchange sheath to facilitate the delivery of ancillary devices during the endovascular AAA procedure.

Prof. Andrew Holden, MBChB, and Andrew Hill, MD, completed a successful first-in-man use of the IntelliFlex LP to implant an Aorfix endovascular stent graft in November 2015. Prof. Holden is Director of Interventional Services and Associate Professor of Radiology at Auckland University School of Medicine. Dr. Hill is from Auckland City Hospital in Auckland, New Zealand.

In the company’s press release, Prof. Holden commented, “The first-in-man procedure with the new IntelliFlex delivery system was extremely straightforward and the device was a real pleasure to use. I particularly appreciated the new Y-mechanism that enables greater control and precision when deploying the graft. This enhanced design 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 IntelliFlex delivery system provides greater control of the Aorfix stent graft when deploying the proximal end of the device near the renal arteries, allowing for very accurate placement. The integrated exchange sheath was really beneficial and the hemostatic valve copes extremely well with multiple catheter exchanges.”

The Aorfix endovascular stent graft system has European CE Mark approval, Japanese regulatory approval, and US Food and Drug Administration approval, advised Lombard Medical.