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Press Release

Positive Five-Year Results from the Global Ovation® Pivotal Trial Presented at 2016 VEITH Symposium


Posted on: 16 Nov 16

IRVINE, Calif., Nov. 16, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of positive 5-year safety and effectiveness clinical data from the global Ovation Pivotal Trial at the 2016 VEITH symposium. The results were presented by Manish Mehta, MD, MPH, Director, Vascular Health Partners of Community Care Physicians, PC and the U.S. principal investigator for the global Ovation Pivotal Trial.

The Ovation Pivotal Trial included a total of 161 patients, enrolled in Chile, Germany and USA from November 2009 to December 2011. Through five years, the key highlights from the data included:

  • Broad patient applicability, with 40% of the patients treated outside the labeled indications of other endovascular aortic repair (EVAR) devices
  • Stable aortic neck diameters with an average expansion of 0.1%, compared to 25% as reported with other EVAR devices 
  • 97.5% Freedom from secondary interventions related to type 1 endoleak
  • No migration or conversions

Dr. Mehta commented, “The five-year data from the Ovation Pivotal Trial confirms the long-term safety and durability of the Ovation system.  The study included the broadest range of AAA patients ever treated in an endovascular AAA IDE trial, and demonstrates the effectiveness of Ovation system’s ultra-low profile delivery system and polymer sealing technology.”

John McDermott, Chief Executive Officer of Endologix, said, “Completion of the five-year follow-up is an important milestone that validates the long-term durability of EVAR with the Ovation system. It also demonstrates the capability that the Ovation system enables physicians to treat more AAA patients than other devices.  We would like to thank Dr. Mehta and all of the investigators for their participation in the clinical trial and congratulate them for their outstanding results.”

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 potential adoption of a Fast-Track protocol by clinicians and hospitals, 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 pressures.  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.

GlobeNewswire
globenewswire.com

Last updated on: 17/11/2016

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