Endologix has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare.
Endologix also recently entered into a distribution agreement with Japan Lifeline, a cardiovascular medical device company in Japan. Japan Lifeline plans to introduce the AFX system in the Japanese market in the first quarter of 2016. In addition to AFX, Endologix’s agreement with Japan Lifeline includes future distribution of the Nellix endovascular aneurysm sealing System in Japan, which is anticipated in 2018.
Bob Mitchell, president of Endologix, said, “There is already positive adoption of our first generation anatomical fixation products in Japan and we believe the next-generation features of AFX will further strengthen adoption. We are working closely with Japan Lifeline to prepare for the AFX launch, along with preparations for a Japanese regulatory submission for the Nellix system.”
The AFX endovascular system provides anatomical fixation with an advanced delivery system and graft material technology to treat a wide range of abdominal aortic aneurysm anatomies. The system’s low profile sheath allows for smooth tracking and precise device deployment. AFX stent grafts are constructed using Endologix’s proprietary DuraPly graft material which is a durable and conformable material featuring enhanced stent graft sealing technology.