US-based Lombard Medical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its AorFlex endovascular stent graft delivery system.
The company is focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), which are balloon-like enlargements of the aorta which, if left untreated, may rupture and cause death.
After securing reimbursement approval, which is expected in April, the company will begin commercial sales. It will receive and ship a significant stocking order ahead of the commercial launch.
The company's exclusive partner in Japan, Medico's Hirata, will be responsible for distribution of the Aorfix endovascular stent graft with the AorFlex delivery system.
Aorfix is the first and only endovascular stent graft approved in Japan for the treatment of AAAs in patients with aortic neck angulations of up to 90 degrees.
Aorfix is also approved for the treatment of patients with neck angles of up to 90 degrees in the US and Europe.
Lombard Medical CEO Simon Hubbert said: "Introducing the more advanced AorFlex delivery system with hydrophilic coating puts the Japanese Aorfix system in line with the other global regions, and will create an even more compelling proposition and help continue the fantastic momentum we have already shown in Japan."
Approximately 4.5 million people are living with AAAs in the developed world, and each year more than 500,000 new cases are diagnosed.
Aortic aneurysm disease is among the leading causes of death in the US and it is estimated that 1.5 million people have an abdominal aortic aneurysm.