IRVINE, Calif., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq: ELGX ), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of two-year 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 2016 VEITH symposium.
The Global Registry data covers a total of 300 patients treated with the Nellix system, enrolled in Europe and New Zealand, with two-year follow-up. Key highlights from the data included:
- 37% of the patients had complex anatomies
- 98% freedom from any persistent endoleaks at latest follow-up
- No secondary interventions for Type II endoleaks
- 97% freedom from aneurysm-related mortality
- 99% freedom from cardiovascular mortality
These data continue to support positive outcomes in a real world patient population that had no screening or anatomical restrictions at enrollment, and constitute the broadest range of aortic anatomies for any prospective endovascular AAA study.
Dr. Holden commented, “The two-year results from the EVAS FORWARD – Global Registry confirm the significant potential for EVAS with Nellix to treat a broad range of patients and provide excellent results, especially within the indications for use. In addition, the continued low rates of aneurysm and cardiovascular-related mortality suggest that EVAS with Nellix may provide additional benefits beyond traditional EVAR.”
John McDermott, Chief Executive Officer of Endologix, said, “We are encouraged by the two-year results from the Nellix EVAS FORWARD – Global Registry and have validated that EVAS with Nellix provides the lowest rates of endoleak of all endovascular AAA technologies. We’d like to thank the study investigators for their ongoing contributions and look forward to initiating Phase 2 of the Registry to include the Nellix Gen2 system and our refined indications, which we expect will provide exceptional clinical outcomes.”
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. Nellix is an investigational device in the United States.
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 United States. 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 superior clinical performance 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 unanticipated clinical outcomes and competitive improvements. 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.
COMPANY CONTACT: Endologix, Inc. John McDermott, CEO Vaseem Mahboob, CFO (949) 595-7200 www.endologix.com INVESTOR CONTACTS: The Ruth Group Nick Laudico (646) 536-7030 Zack Kubow (646) 536-7020
