Lombard Medical Expands European Launch of Altura EVAR System

July 6, 2016—Lombard Medical, Inc. announced the expansion of the European launch to the Netherlands and Spain of the company’s Altura endovascular stent graft system for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms.

Prof. Clark J. Zeebregts, MD; Paul M. van Schaik, MD; and Ignace F. Tielliu, MD, who are consultant vascular surgeons, successfully completed three Altura procedures at the University Medical Center Groningen in the Netherlands.

In the company’s press release, Prof. Zeebregts stated, “After successfully completing three Altura procedures in 1 day, we found the device to be intuitive and simple to use. The removal of the cannulation step required for other systems is a nice feature that will enable us to predict consistent procedure times and ultimately reduce physician and patient x-ray exposure.” Dr. van Schaik added, “We have a large and diverse EVAR practice, and we can see Altura becoming our ‘go to’ endovascular stent graft as we gain more clinical experience over the coming months.”

Nilo J. Mosquera, MD, Head of the Department of Angiology and Surgery, Complexo Hospitalario Universitario, successfully completed the first Altura procedure in Ourense, Spain.

Dr. Mosquera commented in Lombard Medical’s announcement, “We are honored to be the first center in Spain to complete an Altura EVAR procedure. We found the new Altura stent graft easy to use, with a minimal amount of steps required to implant the stent graft. We were especially impressed with the 14-F ultra-low-profile design and the elimination of the gate cannulation step which can be a real procedural time saver.”

The Altura system received European CE Mark approval in 2015. Lombard Medical launched the device in the United Kingdom and Germany in February 2016. A broader international rollout is currently underway.

Lombard Medical intends to file for an investigational device exemption from the US Food and Drug Administration in the summer of 2016, with the intent to begin recruitment for a United States clinical study in the first half of 2017, advised the company.