IRVINE, Calif., March 08, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the first two patients with abdominal aortic aneurysms (“AAAs”) in Japan have been treated with the Nellix® EndoVascular Aneurysm Sealing System (“Nellix EVAS System”). The patients were treated under Japan’s “compassionate use” system, which grants access to physicians for use of medical treatments not yet approved in Japan for patients who are diagnosed with advanced diseases that are not responsive to existing treatment options. The procedures were performed by Toru Kuratani, MD, Ph.D., Chairman of the Department of Minimally Invasive Cardiovascular Medicine at Osaka University Graduate School of Medicine.
Dr. Kuratani commented, “The unique aneurysm sealing technology of the Nellix system presents a significant opportunity to treat AAA patients that previously had no other treatment options. Type II endoleaks occur in over 30% of our EVAR cases in Japan and this device is excellent solution for prevention of this endoleak. In addition, Nellix is very well positioned to treat the anatomical challenges associated with Asian patients, including difficult iliac anatomy. The first two procedures were completed as planned, and the initial imaging confirms that Nellix effectively sealed and treated the AAAs. We look forward to treating more AAA patients under Japan’s compassionate use system.”
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve and long-term patient outcomes. Nellix is an investigational device in the United States.
Bob Mitchell, President of Endologix, said, “We’d like to thank Dr. Kuratani and his team for their collaboration in the first Nellix procedures performed in Japan. We are very pleased that the Nellix system allowed these two Japanese patients to be successfully treated when no other options were available. This highlights the potential of Nellix to treat more patients with AAA in Japan and other markets around the world.”
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.
Forward-Looking Statements
This communication includes statements that may be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the clinical and commercial potential of the Nellix EVAS System, 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 unanticipated clinical outcomes and lack of regulatory approvals. 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, 2015, 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.