Presentations Feature Lombard Medical's Altura and Aorfix EVAR Systems

May 4, 2017—Lombard Medical, Inc. announced that the company's Altura and Aorfix endovascular stent graft systems were featured in presentations at the 39th annual Charing Cross International Symposium, which was held April 25–28 in London, United Kingdom. 

Five-year clinical data on the Altura device, combined from two prospective, international, multicenter studies were presented by Prof. Dainis Krievins, MD. Key findings of the 90-patient data set included: technical success was 99%; percutaneous access was achieved in 57% of patients; only 21% of patients required general anesthesia; there were no abdominal aortic aneurysm–related deaths over the follow-up period; no patients experienced sac expansion; and mean follow-up was 12.4 months. Prof. Krievins commented in Lombard Medical's announcement, “Altura is impressively easy to use based on its 14-F profile, repositionability, and avoidance of cannulation. The performance of the stent graft, as demonstrated in the clinical data, is equivalent to contemporary grafts that do not share these advantages.”

In a presentation of the clinical utility of the Altura, Paul Hayes, MD, used a video case study to demonstrate the ease of use of the system. Dr. Hayes noted Altura’s retrograde limb deployment with built-in contrast injection to aid predictable, shorter procedure times.

According to the company, the Altura is delivered via an ultra-low profile 14-F catheter. The device allows for repositioning during deployment and accurate graft placement at each renal artery, enabling physicians to utilize all of the available aortic neck. It also eliminates the need for cannulation that results in a simple, safe, and consistent deployment with predictable, shorter procedure times.

Lombard Medical advised that the company is initiating a European registry for the Altura system, which has received CE Mark approval and is now available commercially in the United Kingdom and certain other international markets.

A video of an Aorfix case that involved a 90º neck was presented by Prof. Andrew Holden, MBChB, which highlighted the control and precision of the IntelliFlex LP delivery system in placing the proximal part of the stent graft in very challenging anatomies. Prof. Holden stated, “The improvements provided by the IntelliFlex delivery system have made placing the Aorfix graft much more controlled, and it is now very user friendly. With the Y-Mec active opening feature, the built-in exchange sheath, and hemostatic valve, it’s now a device for routine use in the majority of [endovascular aneurysm repair] patients, as well as its unique application in highly angulated and tortuous cases.”

The Aorfix endovascular stent graft has global approvals to treat patients with severe aortic neck angles up to 90º. The new, intuitive, and low-profile IntelliFlex LP delivery system gives a high level of precision and control in treating this range of patient anatomies, advised Lombard Medical. 

In other company news, Lombard Medical announced on April 20 that Kurt Lemvigh has been appointed as its new Chief Executive Officer, effective immediately.