Recommencement of European Clinical Procedures For Second Generation Stent Graft
London, UK, 30 January 2007 - Lombard Medical Technologies PLC (“the Company”) announces that it is recommencing European clinical procedures involving its Generation II Aorfix™ endovascular stent graft. The Company voluntarily suspended sales of the product in December because, in a small number of cases, the surgeon experienced difficulties in placing the stent graft.
Following thorough analysis of intra-operative X-ray films and extensive laboratory testing, the cause of the inaccuracy was isolated to a manufacturing step in which the stent graft is loaded into its delivery tube. The manufacturing process has been adjusted and intensive testing has proven that the device now deploys consistently well.
The Company has worked closely with leading clinicians and regulatory authorities in the UK and Germany to keep them informed of the clinical experience last year and improvements made in the last few weeks.
The first clinical cases are expected to commence on 31st January with further cases scheduled in February and beyond.
Alistair Taylor, Executive Chairman, said:
“We are pleased to have quickly identified and solved the issue concerning the delivery mechanism. The recommencement of clinical procedures is good news for those patients with difficult anatomies for which Aorfix™ is the only possible treatment for their abdominal aortic aneurysm.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / John Gilbert
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™, 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™ is currently being commercialised in the EU, with US clinical trials having commenced during 2006. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug eluting stents and has a number of research collaborations developing novel products for this $6bn market.
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 and Boston, USA, employs over 90 people.
Further background on the Company can be found at www.lombardmedical.com.