IRVINE, Calif., May 17, 2016 (GLOBE NEWSWIRE) -- Lombard Medical, Inc., a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the 30-day clinical results on 57 patients that were implanted with the Altura Endograft System. The 57 patients were implanted 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. The 30-day follow up data on evaluable patients demonstrated the following;
|•Device delivery success||98||%|
|•Freedom from type I/III endoleaks||98||%|
|•Freedom from rupture||100||%|
|•Freedom from conversion to open procedure||100||%|
|•Freedom from graft occlusion||98||%|
“Our Altura clinical experience with more than 45 patients has shown the device to be safe, effective, and very easy to use,” said Dr. Krämer. “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 Fr ultra low profile delivery catheter can also accommodate smaller access vessels that may be compromised due to disease.”
“We are encouraged by the initial 30-day clinical data and look forward to presenting longer term clinical data as more data is gathered across our initial centers,” said CEO Simon Hubbert. “We strongly believe that Altura with its unique 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.”
About Altura Endograft System
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 14 Fr 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 6 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 FDA in 2016 with the intent to begin recruitment for a US clinical study later in 2016.