- 18 (75%) of patients were discharged at or before 24 hours (Day-Case EVAR).
- There were no deaths within 90 days.
- There were no immediate or delayed access-related complications.
- Deployment time ranged 19-45 minutes.
- Mean contrast dose was 150ml.
- Median intraoperative contrast dose was 75ml of 50% concentrate Visipaque 270.
- A further 60ml for rotational angiography at completion in the hybrid lab.
Mr. Steve Richardson, Consultant Vascular Surgeon at University Hospital South Manchester (UHSM), UK, added, "We are extremely pleased with our early experience using Altura, the learning curve is rapid and it has quickly become the 'go to' endograft in our vascular unit."Lombard Medical CEO Simon Hubbert commented, "Altura clearly offers unique benefits to physicians and patients and significantly enhances the treatment of patients with standard AAA anatomy. Its unique features including an ultra-low profile 14F delivery system, the elimination of the unpredictable procedure step of 'stent graft gate cannulation' and retrograde iliac deployment all add up to a simpler, quicker, predictable and safer procedure with optimum outcomes." About Altura Endograft SystemThe 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 the UK and Germany in February 2016 with a broader international rollout currently underway. About Abdominal Aortic Aneurysms (AAAs)AAAs are balloon-like enlargements of the aorta which if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year more than 500,000 new cases are diagnosed. In the U.S., aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm. About Lombard Medical, Inc.Lombard Medical, Inc. is an Oxfordshire, UK-based medical device company focused on the $1.8bn market for minimally invasive treatment of abdominal aortic aneurysms (AAAs). The Company has global regulatory approval for Aorfix™, an endovascular stent graft that has been specifically designed to treat patients with the broadest range of AAA anatomies, including aortic neck angulation up to 90 degrees. The Company has also achieved CE Mark for the Altura® endograft system, an innovative ultra-low profile endovascular stent graft that offers a simple and predictable solution for the treatment of more standard AAA anatomies. For more information, please visit www.lombardmedical.com. Forward-Looking StatementsThis announcement contains forward-looking statements that reflect the Company's current expectations regarding future events. These forward-looking statements generally can be identified by the use of words or phrases such as "believe," "expect," "future," "anticipate," "look forward to," "intend," "plan," "foresee," "may," "should," "will," "estimates," "outlook," "potential," "optimistic," "confidence," "continue," "evolve," "expand," "growth" or words and phrases of similar meaning. Statements that describe objectives, plans or goals also are forward-looking statements. Forward-looking statements are subject to risks, management assumptions and uncertainties. Actual results could differ materially from those projected herein and depend on a number of factors, including the success of the Company's research and development and commercialization strategies, the uncertainties related to the regulatory process and the acceptance of the Company's products by hospitals and other medical professionals, the uncertainty of estimated revenues and profits, the uncertainty of current domestic and international economic conditions that could adversely affect the level of demand for the Company's products and increased volatility in foreign exchange rates, the inability to raise additional funds, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Form 20-F filed with the Securities and Exchange Commission dated April 29, 2016. Readers are urged to consider these factors carefully in evaluating the forward-looking statements. The forward-looking statements included herein are made only as of the date of this report and the Company undertakes no obligation to update these statements in the future.
For further information:Lombard Medical, Inc. Simon Hubbert, Chief Executive Officer +44 (0)1235 750 800William J. Kullback, Chief Financial Officer Tel: +1 858 750 5245