IRVINE, Calif., Nov. 19, 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"). Andrew Holden, MD, Associate Professor of Radiology at Auckland City Hospital (Auckland, New Zealand) and one of the principal investigators of the EVAS FORWARD - Global Registry, presented the results at the 2015 VEITH symposium. The Nellix EVAS 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 14 months. Key highlights from the data included:
- 33% of patients treated had complex AAA anatomies
- Low aneurysm-related mortality (0.4%) and overall major adverse events (5.9%)
- The number of patients with an endoleak at one-year follow-up was 0.7%
- Low re-intervention rate for limb occlusion of 1%
- 95% overall survival through year one
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.
Dr. Holden commented, "The data from the Nellix EVAS FORWARD – Global Registry continue to show promise for EVAS to become a leading therapy in the treatment of patients with AAA. The results show low rates of endoleaks, reinterventions and mortality in a patient population that includes a broad range of AAA anatomies, including many complex cases. In particular, the 0.7% endoleak incidence at one-year represents the lowest overall rate ever reported for any commercially available endovascular device treating AAA. In addition, the low aneurysm-related mortality and major adverse events rates provide an encouraging look at Nellix's positive impact on overall patient health."
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, improve stability and long-term patient outcomes. 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.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, "The presentation of positive one-year follow-up data from the Nellix EVAS FORWARD – Global Registry confirms the positive results from earlier data presentations and adds to our confidence in the long-term durability of the Nellix Aneurysm Sealing System. We'd like to thank our physician investigators for their active participation in the study and assistance with the procedure development and training of this important new technology. Physician interest in Nellix remains strong and we look forward to working towards potential FDA approval by the end of 2016."
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.
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 safety and efficacy of the Nellix EVAS System, regulatory approval of the Nellix EVAS System and interest in 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 results and delays in regulatory submissions and actions. 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.