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August 4, 2014
Lombard Medical's Aorfix EVAR Stent Graft Approved in Japan
August 5, 2014—Lombard Medical, Inc., the United Kingdom–based medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms, announced that the Aorfix endovascular stent graft received approval from the Japanese Ministry of Health, Labor, and Welfare. Aorfix is approved in Japan for EVAR of abdominal aortic aneurysms in patients with aortic neck angulations up to 90°, commonly considered to be challenging cases.
The device will be commercially available in Japan following reimbursement approval, which Lombard anticipates receiving in September. Aorfix will be exclusively distributed in Japan by Medico's Hirata Inc. Aorfix is currently approved to treat patients with neck angles up to 90° in the United States and Europe, advised the company.
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