Positive 12 month Clinical Data for Aorfix™ Stent Graft
London, UK, 12 April 2006 - Lombard Medical Technologies PLC (“Lombard Medical”) announces positive clinical results on its Aorfix™ stent graft, presented yesterday at the 28th Charing Cross International Symposium at Imperial College, London. Twelve month follow-up data on 24 trial patients was reported, demonstrating freedom from all endoleaks, fracture, migration or kinking. In addition, Aorfix™ offers hope to those patients with tortuous anatomy of the abdominal aorta, who were once thought as untreatable by conventional aortic stent grafts. First clinical implants of the improved device and delivery system promise quicker and easier deployment of the stent graft, making it a more comfortable procedure for clinician and patient.
Aorfix™ has been used in more than 130 patients worldwide. Several abdominal aortic aneurysm (AAA) bifurcated stent grafts have exceeded 24 months of implantation with no device related adverse clinical outcomes.
Lombard Medical also reports that NICE (National Institute for Health and Clinical Excellence) has recently issued a new Interventional Procedure Guidance. This confirms that current evidence on the efficacy and short-term safety of stent graft placement in AAA appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.
NICE recommends in particular that patients should understand the risks of endovascular leaks, the possibility of secondary intervention and the need for lifelong follow-up. The most common adverse event reported in a meta-analysis of three randomised controlled trials following stent graft placement was device related endoleaks, which occurred in 19% of patients within the first year. Technical complications included stent migration, which happened in 1% of patients, and stent wire fracture, which happened in 3% of patients, both within the first year. Recent developments, however, such as Lombard Medical’s Aorfix™ device, have led to lower incidence of procedural and post-procedural complications.
Alistair Taylor, Executive Chairman of Lombard Medical, said:
“We have presented highly positive clinical data on our Aorfix™ stent graft, showing excellent results at 12 months, particularly in terms of no endoleaks, strong migration resistance and significant aneurysm shrinkage.
“Aorfix™ will make a real contribution to the development of stent graft placement in AAA by offering less risk and trauma to a wider range of patients than ever before, more clinical choices to medical practitioners and improved cost effectiveness of this procedure.”
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 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™, 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 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 47 people.
Further background on the Company can be found at www.lombardmedical.com.