Endologix Earns Japanese Approval for AAA treatment system

Irvine, Calif.-based Endologix Inc., which makes treatments for aortic disorders, has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its AFX Endovascular AAA system for the treatment of abdominal aortic aneurysms (AAAs).

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.

“We are pleased to receive approval for the AFX system in Japan and to be launching the product with our new partner, Japan Lifeline,” said Bob Mitchell, President of Endologix. “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 EVAS system.”

“We look forward to a strong partnership with Endologix,” said Keisuke Suzuki, President and CEO of Japan Lifeline. “The addition of AFX to our product offering will complement our current product line up of vascular grafts, open stent grafts and thoracic stent grafts to meet the diverse needs of physicians and patients. We are also committed to working with Endologix to gain regulatory approval for the Nellix EndoVascular Aneurysm Sealing System, the next-generation treatment for the abdominal aortic aneurysms.”

The AFX Endovascular AAA 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, the company claims. AFX stent grafts are constructed using Endologix’s proprietary new Duraply graft material which is a durable, highly conformable material featuring enhanced stent graft sealing technology.