Positive data presented on the use of Aorfix
April 06 2009 - 4:00AM
RNS Non-Regulatory
TIDMLMT
Lombard Medical Technologies PLC
06 April 2009
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Press information
Lombard Medical Technologies PLC
("Lombard Medical" or "Company")
Positive Aorfix(TM) Data in Challenging Anatomies Reported at Charing Cross
Symposium
London, UK, 6 April 2009 - Lombard Medical Technologies PLC (AIM: LMT), the
specialist medical device company, announces that Professor Michael Horrocks,
Royal United Hospital, Bath, UK, has presented positive data from the use of
Aorfix(TM) in patients with challenging anatomies at the 31st International
Charing Cross Symposium (4-7th April).
On 5th April Professor Horrocks presented data from Lombard Medical's
Retrospective Aorfix(TM) Data Retrieval ("RADAR") voluntary registry. At the
time of the analysis RADAR contained data on 619 implants out of more than 800
performed to date worldwide. Data for those patients for which sequential
follow-up data was available continued to compare favourably with published data
on the use of other stent grafts:
+---------------------------------------+--------------------------------+
| | Aorfix(TM) |
| | (April 2009) |
+---------------------------------------+--------------------------------+
| All cause 30-day mortality | 1.45% (n=619) |
| (of those fit for open surgery) | |
+---------------------------------------+--------------------------------+
| Stent migration at 12 months | 0% (n=343) |
+---------------------------------------+--------------------------------+
| Wire fracture at 12 months | < 0.5% (n=343) |
+---------------------------------------+--------------------------------+
| Aneurysm rupture at 36 months | 0% (n=64) |
+---------------------------------------+--------------------------------+
| Endoleaks at 12 months | 10.5% (7.6% type II) (n=343) |
+---------------------------------------+--------------------------------+
Information on the aneurysm neck angle is held for 374 of the cases in RADAR and
Professor Horrocks presented excellent clinical data on the performance of
Aorfix(TM) in high-angle-neck patients (mean neck angle 80 ), for which there is
currently no approved endovascular treatment.
These data included an all cause mortality rate at 30-days of just 1.47% for the
high-angle-neck patient group, which is significantly better than that for open
surgery (approx. 4.8%) that is often the only alternative treatment available
for such challenging cases.
Despite the tortuous anatomy of the high-angle-neck patient group, no loss of
patency (i.e. blood flow) or stent migration was observed at one year (n=73) and
endoleak rates at 20.5% were similar to average rates quoted in studies of
endovascular aneurysm repair (EVAR) of less difficult patients. Endoleak rates
at one year for cases with neck-angles of < 60 (n=111) at just 9.0% (7.2% type
II) demonstrated the value of using Aorfix(TM) in normal as well as difficult
cases.
Data was also presented on changes in the aneurysm diameter a year after
implantation. This showed that in 97% of cases there was a decrease or no change
(+/- 3mm) in aneurysm sac diameter indicating that the aneurysm was under
control.
Professor Horrocks commented:
"Aorfix(TM) is likely to increase the number of patients considered suitable for
EVAR who were previously excluded from this type of treatment and also reduce
the risk of endoleaks."
Brian Howlett, CEO of Lombard Medical, commented:
"With more than 800 implantations of the AorfixTM worldwide there is a rapidly
growing body of real world evidence supporting its clinical benefits in treating
patients, this will increase the number of patients considered suitable for
EVAR with difficult anatomies. The data presented by Professor Horrocks at the
Charing Cross Symposium further underlines the major improvements seen in all
cause mortality and other parameters for high-angle-neck patients compared with
current NICE best practice and open surgery."
Enquiries:
+----------------------------------------------+----------------+
| Lombard Medical Technologies PLC | Tel: 01235 750 |
| Simon Neathercoat, Non-executive Chairman | 800 |
| Brian Howlett, Chief Executive Officer | |
| Tim Hall, Finance Director | |
+----------------------------------------------+----------------+
| | |
+----------------------------------------------+----------------+
| Financial Dynamics | Tel: 020 7831 |
| Jonathan Birt / Susan Quigley | 3113 |
+----------------------------------------------+----------------+
| | |
+----------------------------------------------+----------------+
| Nomura Code | Tel: 020 7776 |
| Juliet Thompson / Richard Potts | 1200 |
+----------------------------------------------+----------------+
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent
grafts and other medical products for use in the treatment of vascular disease.
The Company's lead product, Aorfix(TM), is an endovascular stent graft for the
treatment of abdominal aortic aneurysms (AAAs), a balloon-like enlargement of
the aorta which, if untreated, may rupture and cause death. Approximately 1.7
million people have AAAs in the US where it is the 13th largest cause of death.
The market for endovascular stent grafts for the treatment of AAA is currently
worth over $600 million and is expected to grow to around a $1 billion by 2010.
Aorfix(TM) is currently being commercialised in the EU, with a pivotal clinical
trial ongoing in the USA.
The Company's Polymer Coatings Division has developed a novel hydrophilic
surface treatment to reduce friction on catheters called GlideMax(TM), which is
available for licensing, and is using its polymer coating technology in a number
of research collaborations developing novel products for the $5 billion
drug-eluting stent market.
The Company is headquartered in Oxfordshire, with operations in Yorkshire,
Ayrshire and Boston, USA.
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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