IRVINE, Calif., Sept. 29, 2014 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq: ELGX ), developer and marketer of innovative treatments for aortic disorders, announced today that it has completed patient enrollment in the EVAS FORWARD – Global Registry. From October 2013 to September 2014, the registry enrolled 300 patients treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") at centers in Europe and New Zealand. The registry will provide real world clinical results to further demonstrate the effectiveness and broad applicability of the Nellix technology. The primary investigators of the registry are Andrew Holden, MD, Associate Professor of Radiology at Auckland Hospital; and Professor Matthew Thompson, MD, St. Georges Vascular Institute, London.
Professor Thompson said, "The EVAS FORWARD – Global Registry is the first large prospective study to examine the safety and effectiveness of EVAS with the Nellix system. This promising new technology allows physicians to treat a broader range of patients, including many that would not have previously been candidates for the currently available EVAR devices. We have been very pleased with our initial experience and believe that Nellix has the potential to become a leading therapy for patients with abdominal aortic aneurysms."
Patients enrolled in the EVAS FORWARD – Global Registry will be followed for five years, with a primary endpoint evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure. Interim data from the registry is expected to be presented over the course of the five year follow-up period. The next data presentation from the registry is anticipated at the VEITH symposium in November 2014. Dr. Holden is expected to present data from the first 250 patients enrolled in the trial, which will include results at 30-days post procedure or greater.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, "We are pleased to have completed patient enrollment in the EVAS FORWARD – Global Registry ahead of our original expectations. The rapid enrollment is indicative of the strong physician interest in and broad applicability of the Nellix EVAS System. In the U.S., we also continue to make excellent progress with the EVAS FORWARD – IDE clinical trial, which has now enrolled 125 patients and remains on track to complete enrollment by the end of the year."
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. Endologix 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 ® EndoVascular Aneurysm Sealing System has obtained CE Mark in the EU and is only approved as 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 ability of the Nellix system to treat a broader range of patients, the potential of Nellix to become the leading therapy for the treatment of AAA, the timing of the next EVAS FORWARD – Global Registry data presentation, and the broad applicability of the Nellix 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 difficulties in maintaining patient follow-up over a long-term and unanticipated clinical outcomes. 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, 2013, and Endologix's other 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.
COMPANY CONTACT: Endologix, Inc. John McDermott, CEO Shelley Thunen, CFO (949) 595-7200 www.endologix.com INVESTOR CONTACTS: The Ruth Group Nick Laudico (646) 536-7030 Zack Kubow (646) 536-7020
