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December 9, 2015
Endologix AFX Endovascular AAA System Approved in Japan
December 10, 2015—Endologix, Inc. announced that the company’s AFX endovascular abdominal aortic aneurysm (AAA) system has received Shonin regulatory approval from the Japanese Ministry of Health, Labor, and Welfare.
Endologix advised that it has entered into a distribution agreement with Japan Lifeline, which will 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.
According to Endologix, the AFX system provides anatomical fixation with an advanced delivery system and graft material technology to treat a wide range of AAA anatomies. The system's low-profile sheath allows for smooth tracking and precise device deployment. AFX stent grafts are constructed using Endologix’s DuraPly graft material. DuraPly is a durable, highly conformable material that features enhanced stent graft sealing technology.
The AFX Endovascular AAA system received US Food and Drug Administration approval in 2011. The Nellix System is an investigational device in the United States, advised the company.
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