Lombard Medical Begins ALTITUDE Enrollment in United Kingdom

May 15, 2017—Lombard Medical, Inc. announced that it has enrolled and treated the first patient in the company's ALTITUDE global registry to evaluate its Altura endograft system for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs).

The ALTITUDE registry is evaluating the effect of the Altura device, with its novel D-stent EVAR design, on the treatment of AAAs. The registry will enroll 1,000 patients at sites in the United Kingdom and international clinical centers in typical clinical use conditions.

The Altura system received European CE Mark approval in 2015. Lombard Medical launched the device in the United Kingdom and Germany in February 2016. In July 2016, the company announced an expansion of the launch in The Netherlands and Spain.

Paul Hayes, MD, of the Department of Surgery, University of Cambridge and Addenbrooke’s Hospital in Cambridge, United Kingdom, serves as ALTITUDE’s Chief Investigator. In the company's announcement, Dr. Hayes commented, “This registry will allow the clinical community of AAA implanters to gain necessary experience with Altura. Given the system’s ultra-low profile, its repositionability, the elimination of the contralateral cannulation step, and retrograde delivery of the limb sections, this innovative design promises to facilitate a much simpler, faster, more predictable, and consistent deployment of the endograft. The launch of this registry confirms Lombard’s confidence in the product and will allow us to develop a robust data set about long-term outcomes.”

Simon Kreckler, MD, vascular and endovascular surgeon at Addenbrooke’s Hospital, added, “I am encouraged by our positive early clinical experience with Altura. The simplicity of planning, accuracy of deployment, and repositionability could lead to it becoming a workhorse device in the future. The ALTITUDE registry will provide a real-world evaluation of the longer-term outcomes.”