Lombard Medical announces receipt of CE Mark for its Refix™ Endostapler
London, UK, 10 November 2006 - Lombard Medical Technologies PLC (“Lombard Medical”) today announces that it has received a CE Mark for its Refix™ Endostapler (“Refix™”) allowing the product to be marketed in Europe.
Refix™ has been designed initially to provide increased fixation of endovascular stent grafts which treat abdominal and thoracic aortic aneurysms, a balloon-like weakness in the artery wall. The device delivers percutaneously tiny fasteners (staples), which are pushed through both the wall of the stent graft as well as the wall of the aorta, to keep the stent graft firmly in place and prevent it from migrating, reducing the risk of endoleaks.
Endovascular stent grafts provide vascular surgeons and interventional radiologists with a minimally invasive way to treat aneurysms. The stent graft re-routes the flow of blood into the aneurysm, thus avoiding its potential rupture which could otherwise have fatal results.
Lombard Medical is seeking Investigational status for Refix™ in the USA. The investigational study is targeted to begin in early 2007, subject to FDA consent.
Alistair Taylor, Executive Chairman of Lombard Medical, said:
“Refix™ will provide surgeons with a revolutionary, non-invasive method to increase the fixation of stent grafts so preventing migration and possible endoleak. We are very pleased to receive what will be the Company’s second CE Mark during 2006 and look forward to the launch of this exciting product in Europe.”
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.