Regulatory Approval
15 July 2003 - 1:36AM
UK Regulatory
RNS Number:5284N
Lombard Medical PLC
14 July 2003
Lombard Medical plc
14 July 2003
Lombard Medical plc receives CE mark approval for
revolutionary repositional nitinol clip
Lombard Medical plc ("Lombard Medical") today announces that its subsidiary,
Anson Medical Limited, has received CE Mark approval for its revolutionary
repositionable fixation clip developed for use in open surgical repair of
Abdominal Aortic Aneurysms ("AAA"). The Anson RefixTM, which is covered by
worldwide patents pending, is now commercially available in Europe.
The Anson RefixTM repositionable nitinol clip can be used to fix and stabilise
graft material before suturing or to repair leaks that occur after suturing.
Anson RefixTM is a simple device that has been designed to assist with precise
and secure vascular fixation and should help to reduce operating times as well
as ease access at awkward surgical sites. It is approved for tissue to tissue
and graft to tissue fixations for general and vascular surgery.
Stephen Terry of Lombard Medical commented, "The RefixTM approval and launch is
the achievement of the first stage of the focussed strategy announced by Lombard
Medical in January this year. We believe that RefixTM will become an essential
aid to surgeons due to its ease of use and its ability to reach difficult sites,
while its unique, repositionable characteristic allows the clinician to optimise
its position before deployment. We are in the process of finalising distribution
agreements with a number of the key national distributors as part of the
imminent commercial launch of this product. We are also progressing with the
process of FDA approval which would allow us to sell RefixTM in the USA. It is
our intention to expand the range of RefixTM products for use in other areas of
surgery."
Tony Canning, Chairman of Lombard Medical, added, "This is an example of the
ability of Lombard to bring its undoubted innovative skills to commercialisation
and we are confident that there will be further such developments in the future.
"
For further information:
Tony Canning, Chairman
Lombard Medical plc
Tel: 020 7710 4500
Stephen Terry
Lombard Medical plc
Tel: 01235 841760
This information is provided by RNS
The company news service from the London Stock Exchange
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