ALTITUDE Global Registry Will Evaluate Lombard Medical's Altura EVAR Device in Real World Patients

June 16, 2016—Lombard Medical, Inc. announced plans to conduct a global registry to evaluate its new Altura endograft system for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). The ALTITUDE registry (Altura Impact on the Treatment of Abdominal Aortic Aneurysms Using a Novel D-stent EVAR Design) will be conducted outside the United States and evaluate the use of the Altura device in real world patients across a range of clinical centers with a planned enrollment of 1,000 patients starting in late 2016.

The Primary Investigator will be Paul Hayes, MD, of the Department of Surgery, University of Cambridge and Addenbrookes Hospital, in Cambridge, United Kingdom.

Dr. Hayes commented in the company’s press release, “With one of the largest AAA patient populations in the United Kingdom, we have been privileged to study many new endovascular devices for aortic aneurysm repair. The Altura device represents one of the most exciting new endograft designs in recent memory. With a repositionable aortic section, the elimination of the contralateral cannulation step and retrograde delivery of the limb sections, this design should facilitate a much simpler, safer, and consistent deployment. This simplicity should also help with surgical planning and possibly allow patients to be discharged sooner after surgery. The 14-F ultra-low profile delivery catheter can also accommodate smaller access vessels that may be compromised due to disease. I look forward to leading this important new clinical registry and establishing a robust set of clinical data points.”

According to the company, the Altura system offers a simple and predictable treatment option for standard AAA anatomy. Delivered via a 14-F catheter, Altura allows for repositioning during deployment. The platform is available in six sizes, which Lombard says allows the majority of patients who present for EVAR repair to be treated quickly with minimal hospital stay and recovery times.

The Altura system received European CE Mark approval in 2015. Lombard launched the device in Europe in January 2016, with a broader international rollout planned for later this year. In the United States, Lombard 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.