Lombard granted Aorfix IDE by US FDA

London, UK-based Lombard Medical Technologies has received an Investigational Device Exemption approval for the US clinical trial of its Aorfix endovascular stent graft, used in the treatment of abdominal aortic aneurysms.

The first part of the trial, which begins this quarter, will ultimately be conducted in up to 20 centers and will involve over 250 patients with AAAs and with neck angulations of 60 degrees or less. These will be compared with a control group of 110 patients unsuitable for endovascular graft therapy, who will receive conventional open surgery. The firm expects recruitement to take approximately 12-15 months and patients will be followed up for a year which includes CT imaging to check for graft integrity and endoleaks.

Lombard will receive revenues for the clinical trials in the USA and, once recruitment has been completed, the Food and Drug Administration will permit the use of Aorfix, pre-approval, in the indications covered by the IDE in those centers that participated in the study.