Updated on 16 March 2015
Lombard Medical Inc., an Irvine-based medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), has received approval for the AorFlexTM delivery system from the Japanese Ministry of Health, Labour and Welfare.
Commercial sales will follow reimbursement approval, which the company anticipates receiving in April, and the company will receive and ship a significant stocking order in advance of the commercial launch.
The Aorfix endovascular stent graft with the AorFlex delivery system will be distributed by the company's exclusive partner in Japan, Medico's Hirata Inc., one of Japan's leading suppliers of vascular products with proven expertise in building significant market share for AAA stent grafts. Japan is said to be the world's second largest, standalone EVAR market.
The company claims that Aorfix is the first and only endovascular stent graft approved in Japan to treat AAAs in patients with aortic neck angulations up to 90 degrees, commonly considered to be challenging cases. Aorfix is also currently approved to treat patients with neck angles up to 90 degrees in the US and Europe.
The EVAR market in Japan is estimated at $150 million, or 10 percent, of the global market in 2014, and has been growing at an average rate of 18 percent over the last five years. In Japan, there are approximately 400 physicians at 200 clinics performing EVAR and it is estimated that approximately 55 percent of Japanese AAA patients are treated using this method.1