OXFORDSHIRE, U.K.--(BUSINESS WIRE)--May 4, 2017--
Lombard Medical, Inc. (NASDAQ: EVAR), a developer, manufacturer and
marketer of endovascular aortic aneurysm repair products, today
announced that its portfolio of endovascular stent graft systems,
Altura® and Aorfix™, were featured in scientific presentations at the 39th
annual Charing Cross International Symposium in London on April 25 - 26.
Altura clinical data combined from two prospective international
multicentre studies were presented at Charing Cross in a paper titled ‘A
new low-profile device approach - results out to 5 years’ by Prof.
Dainis Krievins, of the Paul Stradins University Hospital, Riga, Latvia,
on behalf of the study investigators.
Key findings of the 90-patient dataset were as follows:
Technical success was 99%
Percutaneous access was achieved in 57% of patients
Only 21% of patients required general anaesthesia
There were no abdominal aortic aneurysm (AAA)-related deaths over the
period of follow-up
No patients suffered sac expansion
Mean follow-up of 12.4 months
Prof. Krievins commenting on the results said, “Altura is impressively
easy to use based on its 14Fr profile, repositionability and avoidance
of cannulation. The performance of the stent graft, as demonstrated in
the clinical data, is equivalent to contemporary grafts that do not
share these advantages.”
In a second presentation about the clinical utility of Altura, Paul
Hayes, vascular surgeon at Addenbrookes Hospital, Cambridge, UK, used a
video case study to demonstrate the ease of use of the system. Hayes
cited Altura’s unique retrograde limb deployment with built-in contrast
injection in aiding predictable, shorter, procedure times.
Lombard is initiating a European registry for the CE-marked Altura
system which is now available commercially in the U.K. and certain other
international markets. The Altura system represents a paradigm shift in
endograft design offering a simple and predictable 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 to be treated quickly with minimal hospital
stay and recovery times.
Also at Charing Cross, Prof. Andrew Holden of Auckland City Hospital,
New Zealand, in a video of an Aorfix case that involved a 90-degree
neck, demonstrated the new IntelliFlex™ LP delivery system highlighting
control and precision in placing the proximal part of the stent graft
even in very challenging anatomies.
“The improvements provided by the IntelliFlex delivery system have made
placing the Aorfix graft much more controlled, and it is now very user
friendly. With the Y-Mec active opening feature, the built-in exchange
sheath and haemostatic valve, it’s now a device for routine use in the
majority of EVAR patients, as well as its unique application in highly
angulated and tortuous cases,” said Prof. Holden.
Aorfix is the only endovascular stent graft with global approvals to
treat patients with severe aortic neck angles up to 90 degrees. The new,
intuitive and low-profile IntelliFlex LP Delivery System gives a high
level of precision and control in treating this range of patient
About Lombard Medical, Inc.
Lombard Medical, Inc. based in Oxfordshire, U.K. develops, manufactures
and markets an innovative range of minimally invasive abdominal aortic
aneurysm endovascular repair products. For more information, please
This 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 May 1, 2017. 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.
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Source: Lombard Medical, Inc.
Lombard Medical, Inc.
Kurt Lemvigh, +44 (0)1235 750 800