Lombard Medical Initiating Study to Evaluate Altura Stent

Lombard Medical Inc., a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), has announced plans to conduct a 1,000 patient global registry to evaluate its new Altura Endograft System.

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 will evaluate the use of the Altura Endograft Stent System 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, M.D., F.R.C.S., of the Department of Surgery, University of Cambridge and Addenbrookes Hospital in Cambridge, United Kingdom. 
 
“With one of the largest AAA patient populations in the UK, we have been privileged to study many new endovascular devices for aortic aneurysm repair,” said Hayes. “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 14F ultra-low profile delivery catheter can also accommodate smaller access vessels that may be compromised due to disease. I look forward to leading this new clinical registry and establishing a robust set of clinical data points.”
 
“The ALTITUDE registry will provide real world clinical feedback on the performance of our Altura Endograft System,” said CEO Simon Hubbert.  “We are honored to have Dr. Hayes as our principal investigator, and we look forward to his leadership with this registry. We strongly believe that Altura with its features provides physicians with a system that delivers a safer, more simplified and faster EVAR procedure than currently available stent grafts treating mainstream AAA anatomy. The ALTITUDE registry will help support the adoption of Altura when treating more routine AAAs.”
 
The Altura system represents a paradigm shift in endograft design that offers a simple and predictable treatment option for standard AAA anatomy. Delivered via an ultra-low profile 14F catheter, Altura 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. With just six product sizes, the Altura system 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 CE Mark 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 IDE (Investigational Device Exemption) from the U.S. Food and Drug Administration in the summer of 2016 with the intent to begin recruitment for a U.S. clinical study in the first half of 2017.
 
Lombard Medical is an Irvine, Calif.-based medical device company focused on the $1.7 billionn market for minimally invasive treatment of abdominal aortic aneurysms. The company has global regulatory approval for Aorfix, an endovascular stent graft which has been specifically designed to treat patients with the broadest range of AAA anatomies, including aortic neck angulation up to 90 degrees.