Lombard Medical Receives Full FDA Approval of its Supplemental IDE to Pivotal US Clinical Trial
London, UK, 30 July 2007 – Lombard Medical Technologies plc (“Lombard Medical” or “the Company”) today announces that it has received full supplemental IDE approval for its Aorfix™ endovascular stent graft US Pythagoras clinical trial for abdominal aortic aneurysms (AAA). The supplement now permits the endovascular treatment of patients with aneurysms with infrarenal necks from 0 to 90 degrees, using the flexible Aorfix Generation 2 delivery system that has been available in EU since April 2006. Currently available stent grafts in the US are not approved for patients with aneurysm necks from 60 to 90 degrees of angulation.
To date there have been 17 successful implants of Aorfix in the US from 10 centres, with excellent clinical outcomes in up to 12 months follow up.
The supplement increases the number of trial centres to 20, and reduces the number of patients to be enrolled from 385 to 200 cases. Recruitment into the trial is expected to accelerate with the increased number of centres and the broadened entry criteria from a patient population of unmet clinical need. These factors, will allow the trial to complete more quickly, and at lower cost, than previously planned.
The company plans to have 20 active investigational sites across the US by Q3 2007 and is keen that vascular centers across the country are aware that an endovascular option to treat these anatomies is now available through trial enrollment.
Dr Mark Fillinger, the Principal Investigator for the trial who has already enrolled and treated the first patient with an aneurysm neck angulation of 60 to 90 degrees under this supplement, said:
“The disease in this case had caused a sharp angulation in the aorta to 79°, which the trial is specifically designed to address. In addition, there was a less-than-ideal cone shape to the attachment site, and a sharp angulation above the attachment site as well. I do not believe that any other available stent graft could have treated this aneurysm properly, and the patient had been waiting for Aorfix™ to become available in this clinical trial. We are very pleased with the result and so is the patient.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Brian Howlett, Chief Executive Officer
Lombard Medical Technologies, Inc. (US) Tel: 617 527 4100
Peter Phillips, President
Jan Champion, Intl Director, Clinical and Regulatory Affairs
Financial Dynamics Tel: 020 7831 3113
David Yates/John Gilbert
Nomura Code Tel: 020 7776 1200
Richard Potts
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.
The Company, headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA, employs over 90 people.
Further background on the Company can be found at www.lombardmedical.com.