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Lombard Medical Releases Results from the Altura Endograft System Clinical Evaluation


Lombard Medical, Inc. (NASDAQ: EVAR), 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 14F 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."

Posted-In: News FDA Press Releases


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