IRVINE, Calif., April 29, 2015 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of updated clinical data from the Company's EVAS FORWARD – Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System"). Professor Matt Thompson, MD, St. Georges Vascular Institute, London, one of the principal investigators of the EVAS FORWARD – Global Registry, presented the results at the Charing Cross Symposium in London. The System is approved for investigational use only in the U.S
Global Registry data includes a total of 300 patients with a mean follow-up of 10 months and a range from 0 to 17 months. Key highlights from the data included:
- 35% of patients treated had complex AAA anatomies.
- The number of patients with an endoleak at the latest follow-up was 0.7%.
- 0% device-related mortality.
Early results from the registry were presented last year in New York. These data continue to support very positive outcomes in a patient population that had no screening or anatomical restrictions at enrollment, and constitute the broadest range of aortic anatomies for any AAA study.
Prof. Thompson commented, "Results from the Nellix EVAS FORWARD – Global Registry continue to be very promising, including low rates of endoleaks, reinterventions and mortality. The early data is impressive, especially considering the limited experience that many investigators had with the EVAS technology and the broad range of AAA anatomies treated in the study."
From October 2013 to September 2014, clinical investigators enrolled 300 patients treated with the Nellix EVAS System at centers in Europe and New Zealand. The study includes core lab assessment of CT scans and independent physician adjudication of outcomes. Patients enrolled in the EVAS FORWARD – Global Registry will be followed for five years, with primary endpoints evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure.
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 mitigate all types of endoleaks, improve stability and long-term patient outcomes. Additional interim data are expected to be presented over the course of the five-year follow-up period, with the next presentation anticipated in the fall of 2015.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, "The Nellix EVAS FORWARD – Global Registry data continues to look promising and we are extremely pleased with the early results. The Nellix aneurysm sac sealing technology offers the potential to improve long-term durability and treat more AAA patients than EVAR devices. We sincerely appreciate the efforts of our clinical investigators and look forward to collaborating with them and other physicians to make Nellix available to more patients around the world in the years ahead."
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 EVAS System to treat a broader range of patients, the potential of the Nellix EVAS System 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 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 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 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.
CONTACT: 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) 536-7020Source:Endologix