08.06.14
Irvine, Calif.-based Lombard Medical Inc., a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA), has earned approval from the Japanese Ministry of Health, Labour and Welfare for its lead product, Aorfix. The device is an endovascular stent graft to treat AAA. Commercial sales will follow reimbursement approval, which the company anticipates receiving in September. Aorfix will be exclusively distributed by Medico’s Hirata Inc., a Japanese supplier 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.
According to Lombard, 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.
AAAs are balloon-like enlargements of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year over 500,000 new cases are diagnosed. In the US, aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.
“Japan is a substantial EVAR market – both strategically and financially—and the approval of Aorfix is a significant milestone for the company,” said CEO Simon Hubbert. “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.”
“This approval of Aorfix allows us to provide physicians with a new, minimally invasive treatment option for Japanese patients with challenging AAAs,” said Masataka Hirata, president of Medico’s Hirata Inc. “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 percent of the global market in 2013, 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.
According to Lombard, 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.
AAAs are balloon-like enlargements of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year over 500,000 new cases are diagnosed. In the US, aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.
“Japan is a substantial EVAR market – both strategically and financially—and the approval of Aorfix is a significant milestone for the company,” said CEO Simon Hubbert. “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.”
“This approval of Aorfix allows us to provide physicians with a new, minimally invasive treatment option for Japanese patients with challenging AAAs,” said Masataka Hirata, president of Medico’s Hirata Inc. “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 percent of the global market in 2013, 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.