Commercial sales will follow reimbursement approval, which the Company anticipates receiving in September. Aorfix will be exclusively distributed by 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 the world’s second largest, standalone EVAR market.
Aorfix is the first and only endovascular stent graft approved in Japan to treat AAA in patients with aortic neck angulations up to 90 degrees, commonly considered to be challenging cases. Aorfix is currently approved to treat patients with neck angles up to 90 degrees in the US and Europe.
Lombard Medical’s CEO Simon Hubbert commented, "Japan is a substantial EVAR market – both strategically and financially – and the approval of Aorfix is a significant milestone for the Company. We are confident that, through Medico’s Hirata’s experienced and established sales force, we will be able to realize the full potential of Aorfix in this growing market. 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."
Masataka Hirata, President of Medico’s Hirata Inc., said, "This approval of Aorfix allows us to provide physicians with a new, minimally invasive treatment option for Japanese patients with challenging AAAs. These physicians would otherwise have had to choose between taking responsibility for attempting treatment with a stent graft not specifically approved for more complex AAA anatomies, or resorting to open surgery, which is more invasive and, typically, carries higher associated risks."
The EVAR market in Japan is estimated at $140 million or 10% of the global market in 2013, 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 AAA patients are treated using this method.
