Lombard gets all-clear to test AAA Aorfix graft in US clinical trial:
This article was originally published in Clinica
The US FDA has given Lombard Medical Technologies the go-ahead to begin a clinical trial of its Aorfix endovascular stent graft for treating abdominal aortic aneurysms (AAAs). The first part of the trial, which the UK firm said would begin this quarter, will be conducted at 20 centres and will involve over 250 patients with AAAs and with aortic neck angulations of 60degrees or less being treated with Aorfix. These patients will be compared with a control group of 110 subjects unsuitable for endovascular graft therapy, who will receive conventional open surgery. Recruitment is expected to take 12-15 months and patients will be followed up for a year. Aorfix is currently being commercialised in Europe, said the Didcot, Oxfordshire-based company.