Apr 11 2016
IRVINE, California (GLOBE NEWSWIRE)—Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today achievement of CE (Conformite Europeenne) Mark of the next-generation Nellix Endovascular Aneurysm Sealing System (“Nellix EVAS System”). The first procedures with the new Nellix EVAS System were performed by Associate Professor Andrew Holden and Dr. Andrew Hill at Auckland City Hospital, Auckland, New Zealand.
Dr. Holden commented, “The new Nellix system includes more sizes to treat a wider range of abdominal aortic aneurysm (“AAA”) patients, plus gives us the ability to precisely treat patients with complex iliac anatomy. In our hospital, patients with short or aneurysmal iliac arteries represent 30% of the diagnosed AAAs. With the new Nellix system, we now have a solution for these challenging anatomies and look forward to treating more patients. The first procedures with the new Nellix system have been a success and post-procedure imaging confirmed the device was accurately deployed and the aneurysm was properly sealed.”
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. This next-generation Nellix EVAS System incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the United States.
John McDermott, Chief Executive Officer, said, “The new Nellix system was developed based upon physician feedback over the past two years. It incorporates several enhancements that simplify the procedure and expand the available sizes to treat a wider range of AAA patients and anatomies. We’d like to thank our physician collaborators for their many contributions during the development process and look forward to continued EVAS innovations in the future.”
Mr. McDermott continued, “The new Nellix system will be gradually introduced in Europe and other markets over the next several months, and is the same device we plan to launch in the U.S. following FDA approval. We recently submitted our final postmarket approval (“PMA”) modules to the FDA and remain on schedule for potential PMA approval at the end of 2016 or early 2017.”
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.
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, and U.S. regulatory approval, 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 delays in the regulatory approval process. 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.
John McDermott, CEO
Vaseem Mahboob, CFO
The Ruth Group
Nick Laudico (646) 536-7030
Zack Kubow (646) 536-7020