LMT Lombard Med.Tec

RNS Number:5668Y
Lombard Medical Technologies PLC
17 February 2006





   Lombard Medical receives full IDE approval for its US clinical trial of its
                               Aorfix(TM) stent graft



London, UK, 17 February 2006 - Lombard Medical Technologies PLC (AIM: LMT)
reports today that it has received Investigational Device Exemption (IDE)
approval for its US clinical trial of its Aorfix(TM) endovascular stent graft,
used in the treatment of abdominal aortic aneurysms (AAAs).



The first part of the trial, which begins this quarter, will ultimately be
conducted in up to 20 centres and will involve over 250 patients with AAAs and
with neck angulations of 60degrees or less being treated with Aorfix(TM).  These
will be compared with a control group of 110 patients unsuitable for
endovascular graft therapy, who will receive conventional open surgery.
Recruitment is expected to take approximately 12 to 15 months and patients are
followed up for a year which includes CT imaging to check for graft integrity
and endoleaks.



Lombard will receive revenues for the clinical trials in the US and once
recruitment of the US trial has been completed, the FDA will permit the use of
Aorfix, pre-approval, in the indications covered by the IDE in those centres
that participated in the trial.



The Company is pleased to have Dr Ron Fairman of the University of Pennsylvania
as Principal Investigator for the study.  Dr Fairman is a leader in this field
and was the Principal Investigator for a Medtronic thoracic aortic aneurysm
stent study.



For the second part of the trial, a supplemental IDE will also be filed with the
FDA part-way through the trial for approval of a third arm to be added to the
study to include a further 110 patients with a neck angulation of greater than
60degrees.  There is currently no endovascular stent graft approved for use in
patients with such a high neck angulation in the USA.



Alistair Taylor, Executive Chairman of Lombard, commented:



"We are extremely happy to have received the IDE approval, and it is a
significant step for Lombard towards commercialisation of its Aorfix(TM) stent
graft in the important US market.



"There is a large opportunity in the AAA market for a second generation stent
graft, and we believe that Aorfix(TM) is the only one that addresses the
limitations of existing devices."







Enquiries:


Lombard Medical Technologies PLC
Tel: 01235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer


Financial Dynamics
Tel: 020 7831 3113
David Yates / John Gilbert




Notes to editors

Lombard Medical Technologies is a medical devices company developing stent
grafts and other medical products for use in the treatment of vascular disease.
The Company's lead product, Aorfix(TM), is a stent graft for the treatment of
aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated,
may rupture and cause death.  Abdominal and thoracic aortic aneurysms are the
13th largest cause of death in the US and the market is estimated to be worth
approximately US$2 billion by 2010.  Aorfix(TM) is currently being
commercialised in the EU, with US clinical trials expected to commence during
2006.  The Company has a strategic collaboration with one of the world's leading
medical devices companies, Boston Scientific.



Lombard Medical has recently successfully completed its initial public offering
on AIM and was admitted to listing in December 2005, raising #23.9 million, net
of expenses.  The Company, based in Oxfordshire & Yorkshire, currently employs
50 people.



Further background on the Company can be found at www.lombardmedical.com.




                      This information is provided by RNS
            The company news service from the London Stock Exchange
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