First US Case in a Patient with a High Angle Neck Aneurysm using Gen II Aorfix™
London, UK, 13 July 2007 - Lombard Medical Technologies PLC (“Lombard Medical”) today announces that it has successfully performed the first endovascular stent graft implantation to treat an abdominal aortic aneurysm (“AAA”) with a neck angle of greater than 60° in its pivotal US clinical trial for Aorfix™. The procedure was performed using the improved version of Aorfix™ (“Gen II”) approved by the FDA for the clinical trial in April.
The case was the first to be performed under the revised protocol for the clinical trial that extends the entry criteria to add patients with aneurysm neck angles from 60° to 90°. Neck angulations of this severity have no licensed endoluminal treatment in the US and if successful, the trial will result in a unique label claim for Aorfix™. The FDA gave conditional approval for the extended protocol this May.
It is estimated that between 10 and 15% of patients have aneurysms with neck angles over 60° representing a significant segment of the total AAA market forecast to be worth almost $1bn by the end of the decade.
Dr Mark Fillinger, who performed the procedure at Dartmouth Hitchcock Medical Center, Lebanon, NH, 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.”
Alistair Taylor, Executive Chairman, said:
“We are delighted with the outcome of this case. It demonstrates the ability of the Gen II device to expand endovascular treatment of AAA to this large sub-group of patients and it indicates the potential for the product in the United States. We expect that our clinical trial will accelerate with the expanded protocol using this exciting device.”
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.
The Company, headquartered in Oxfordshire, with operations in Yorkshire and Boston, USA, employs over 90 people.
Further background on the Company can be found at www.lombardmedical.com.