Lombard Medical receives regulatory approval in Japan for AorFlex Endovascular Stent Graft Delivery System


Lombard Medical has announced that it has received approval for the AorFlex 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, one of Japan’s leading suppliers of vascular products with proven expertise in building significant market share for abdominal aortic aneurysm stent grafts. Japan is the world’s second largest, standalone EVAR market.

According to Lombard Medical, Aorfix is the first and only endovascular stent graft approved in Japan to treat abdominal aortic aneurysm 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 USA and Europe.

Lombard Medical CEO Simon Hubbert commented, “The Medico’s Hirata established sales force has made a great start since launching Aorfix in September 2014. 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.”

The EVAR market in Japan is estimated at US$150 million, or 10%, of the global market in 2014, and has been growing at an average rate of 18% over the last five years. In Japan, there are approximately 400 physicians at 200 clinics performing EVAR and it is estimated that approximately 55% of Japanese abdominal aortic aneurysm patients are treated using this method.