Medical device company Lombard Medical’s endovascular stent graft Aorfix has secured approval from the Japanese Ministry of Health, Labour and Welfare.
Aorfix is used in the treatment of abdominal aortic aneurysms (AAA), according to the company.
Commercial sales of the product will begin, after the reimbursement approval, which is expected in September 2014.
The company has selected Medico’s Hirata as exclusive distributor of Aorfix in the country.
Lombard said that Aorfix is the only endovascular stent graft approved in Japan to treat AAA in patients with aortic neck angulations up to 90 degrees.
Currently, Aorfix has been approved to treat patients with neck angles up to 90 degrees in the US and Europe.
Lombard Medical CEO Simon Hubbert said that Medico’s Hirata’s experienced and established sales force will help to realize the full potential of Aorfix in the growing market of Japan.
"We look forward to providing Japanese physicians with our uniquely differentiated stent graft approved to address the significant population of patients with complex anatomies who, until today, had no ‘on-label’ minimally invasive treatment option," added Hubbert.
Medico’s Hirata president Masataka Hirata said, "This approval of Aorfix allows us to provide physicians with a new, minimally invasive treatment option for Japanese patients with challenging AAAs."
AAAs are balloon-like enlargements of the aorta. If untreated, AAAs may rupture and cause death.