IRVINE, Calif., Dec. 10, 2015 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the AFX® Endovascular AAA System for the treatment of abdominal aortic aneurysms has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW).
Endologix also recently entered into a distribution agreement with Japan Lifeline, a leading 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, "We are pleased to receive approval for the AFX System in Japan and to be launching the product with our new partner, Japan Lifeline. 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. 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," said Keisuke Suzuki, President and CEO of Japan Lifeline.
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. 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.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's website at www.endologix.com. The Nellix System is an investigational device in the United States.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the introduction and adoption of the AFX system in Japan and the regulatory prospects of the Nellix system in Japan, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including clinician acceptance, reimbursement approval, and unanticipated clinical results and regulatory hurdles. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2014, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.