Lombard Medical Receives Conditional FDA Approval of its Supplemental IDE to Pivotal US Clinical Trial
London, UK, 29 May 2007 - Lombard Medical Technologies PLC (“Lombard Medical”) has received conditional FDA approval for its Aorfix™ endovascular stent graft US pivotal clinical trial. Lombard Medical filed in April 2007 a supplement to its investigational device exemption (IDE) to increase the scope of patient recruitment, reduce the total number of cases, and for a change to the surgical control arm as detailed below.
The Aorfix™ is used to treat abdominal aortic aneurysms (AAAs) and the supplement broadens the entry criteria to include patients with aneurysm neck angulations of up to 90°. Neck angulations of this severity have no licensed endoluminal treatment in the US; if successful, the trial will result in a unique label claim for Aorfix™.
The supplement increases the number of trial centres from 10 to 20, and reduces the number of patients to be enrolled. Recruitment into the trial is expected to accelerate with the increased number of centres and the broadened entry criteria. These factors, combined with the reduced size of the trial from 385 to 200 cases, will allow the trial to complete more quickly, and at less cost, than previously planned.
The supplement uses historical data for part of the control arm resulting in a reduction in the number of open surgery control cases from 110 to 75, providing a proportional reduction in cost.
The approval has been granted on the condition that a wording change and an information update are provided within 45 days; however this does not delay the implementation of the changes that are the subject of the supplemental IDE.
Alistair Taylor, Executive Chairman, said:
“We are pleased to have received conditional approval for these changes that will not only help to complete the trial more quickly and at reduced cost but will, for the first time, allow patients with severe aortic deformities to be treated with an approved endoluminal product.”
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.