Lombard Medical Announces Filing of Supplemental IDE to Pivotal US Clinical Trial for Aorfix™ and Provides Progress Update
London, UK, 23 April 2007 - Lombard Medical Technologies PLC (“Lombard Medical”) has filed a supplement to its investigational device exemption (IDE) application with respect to the pivotal US clinical trial of its Aorfix™ endovascular stent graft in the treatment of abdominal aortic aneurysms (AAAs). This supplemental IDE requests permission to widen the trial entry criteria to include patients with aneurysm neck angulations of up to 90°, to increase the number of trial centres to twenty and to reduce the overall number of enrolled patients from 385 to 220. The changes proposed are expected to be reviewed by the FDA in the next five weeks.
These changes follow discussions with clinical investigators and the FDA, and are primarily designed to allow the use of Aorfix™ in that cohort of complex patients with aneurysms with neck-angulations of 60° to 90° for which there is no licensed endovascular treatment option. It is anticipated that the unmet medical need of such patients will have a positive affect on recruitment rates in Lombard Medical’s pivotal US trial.
The proposed increase in the number of clinical centres will also assist recruitment into the trial whilst the reduction in overall trial numbers would reduce the length of the trial. If approved Lombard Medical expects trial recruitment to complete in Q1 2008 after allowing for an interim review by the FDA on the data from the first 21 cases.
The US clinical trial of the already CE marked Aorfix™ is currently gaining momentum with eleven US Aorfix™ implants performed to date, of which five have been performed in the last month. Nine centres have so far contributed to the trial and 19 open surgery control procedures have been performed.
Alistair Taylor, Executive Chairman, said:
“If approved, the new changes to the US clinical trial will not only reduce the length and cost of the trial, but will also open it up to a new cohort of previously untreatable patients, providing a much needed solution for those with aneurysms with neck-angulations of between 60 and 90 degrees. We are pleased with the progress made in the trial and are confident that the momentum will continue to build as the improved version of Aorfix™ is employed.”
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
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.