05.08.2014 12:08:46
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Lombard Medical's Aorfix Gets Regulatory Approval In Japan For Treatment Of AAA
(RTTNews) - Lombard Medical Inc. (EVAR), a medical device company focused on Endovascular Aneurysm Repair or EVAR of abdominal aortic aneurysms or AAA, announced that its product, Aorfix, an endovascular stent graft to treat AAA, has received approval from the Japanese Ministry of Health, Labour and Welfare. 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.
Aorfix is 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 $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.
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