US EndoRefix™ Pivotal Trial commences
London,
EndoRefix™ is designed initially to provide fixation of endovascular stent grafts which treat abdominal aortic aneurysms (“AAAs”). The device delivers endovascularly 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. There are approximately 35,000 endovascular AAA procedures performed in the
Medtronic, Inc. will market EndoRefix™ in the
The
“The introduction of the EndoRefix™ System to the
The trial protocol approved by the FDA is for 95 patients to be recruited at 10 centres and followed up for a period of 30 days. Currently two centres have obtained approval of the trial protocol from their Investigational Review Board (“IRB”) and IRB approval is being actively sought in the remaining eight centres. Trial recruitment is expected to be completed by the end of July and the clinical data submitted to the FDA in September for market consideration that may be received by the end of 2008.
Brian Howlett, Chief Executive of Lombard Medical, commented:
“We are very pleased with the positive feedback from Dr Ramaiah and other clinicians who have used EndoRefix™. The
Enquiries:
Lombard Medical Technologies PLC Tel: +44 (0) 1235 750 800
Simon Neathercoat, Non-executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: +44 (0) 20 7831 3113
David Yates / Susan Quigley
Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200
Juliet Thompson / Richard Potts
Notes to editors
About
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 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
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™ is currently being commercialised in the EU, with a pivotal clinical trial ongoing in the
The Company headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and