Early Clinical Results Reported for Lombard Medical's Altura Endograft System

May 17, 2016—Lombard Medical, Inc. announced early clinical results from 57 patients who underwent implantation of the company’s Altura endograft system for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. In the 30-day follow-up data on evaluable patients, the Altura device demonstrated 98% device delivery success, 98% freedom from type I/III endoleaks, 100% freedom from rupture, 100% freedom from conversion to open procedure, and 98% freedom from graft occlusion.

The 57 patients were treated by Albrecht Krämer, MD, at the Pontificia Universidad Católica de Chile Hospital in Santiago, Chile, and Dainis Krievins, MD, PhD, Professor & Department Head of Vascular & Endovascular Surgery at the Pauls Stradins Clinical University Hospital in Riga, Latvia.  

In Lombard Medical’s press release, Dr. Krämer stated, “Our Altura clinical experience with more than 45 patients has shown the device to be safe, effective, and very easy to use. The device also eliminates the need for contralateral cannulation that results in a simple, safe, and consistent deployment. From a safety perspective, I appreciate the retrograde delivery of the limb sections of the device that virtually eliminates the possibility of occluding any branch vessels, while having the ability to reposition the device before final deployment. The 14-F ultra-low-profile delivery catheter can also accommodate smaller access vessels that may be compromised due to disease.”

The Altura system received CE Mark approval in 2015 and was launched in Europe in January 2016. A broader international rollout is planned for later this year. Lombard Medical acquired the device's developer, Altura Medical, in July 2015.  

In the United States, the company intends to file for an investigational device exemption from the US Food and Drug Administration in 2016, with the intention to begin recruitment for a United States clinical study later in the year.

With six sizes, the Altura system allows the majority of patients who present for EVAR to be treated quickly, with minimal hospital stay and recovery times, stated Lombard Medical.