Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced the first results from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair (Polymer EVAR) using Ovation® Abdominal Stent Graft Systems.
ENCORE is a pooled, retrospective analysis of six prospectively enrolled clinical trials and registries of Ovation Abdominal Stent Graft Systems encompassing 1,296 patients, 160 centers and 339 investigators in the U.S., Europe and Latin America. This contemporary analysis standardizes outcome variables across each study. The data is a mix of real world registry and controlled data, and all endpoints are presented using Kaplan-Meier survival estimates.
Median follow up across all studies was 883 days (range 30 days – 5 years). At five years, the ENCORE analysis included the following results for Ovation based on the available data:
- 99.1% freedom from AAA-related mortality
- 99.0% freedom from reintervention for Type 1a endoleak
- 99.7% freedom from rupture
- 99.2% freedom from conversion
- 96.4% freedom from all device-related reintervention
“With ENCORE, our objective was to conduct a rigorous, global evaluation of the available Polymer EVAR clinical data, which includes nearly 1,300 patients, and to share the consolidated results with physicians worldwide,” said Matt Thompson, M.D., Chief Medical Officer for Endologix. “We look forward to sharing additional analyses from the ENCORE data set in the future, and we’d like to thank all of the clinical investigators who participated in the underlying studies that are the basis for the ENCORE analysis.”
Conference Call
The Company will host a conference call at 8:30 a.m. ET on Tuesday, March 20, 2018 to discuss the information contained in this press release and answer questions related to the ENCORE analysis. To participate in the conference call, dial 888-394-8218 (domestic) or 323-794-2149 (international).
The conference call will also be webcast and can be accessed from the "Investors" section of the Company's website at www.endologix.com. The webcast replay of the call will be available at the same site, approximately one hour after the end of the call.
A recording of the call will also be available from 11:30 a.m. ET on Tuesday, March 20, 2018, until 11:59 p.m. ET on Tuesday, March 27, 2018. To hear this recording, dial 844-512-2921 (domestic) or 412-317-6671 (international) and enter the passcode 2955995.
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. For more information, visit www.endologix.com.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” "continue," "outlook," “guidance,” "future,” other words of similar meaning and the use of future dates. Forward-looking statements used in this press release include, but are not limited to, statements regarding the ENCORE analysis and presentation of further results, the accuracy of which are necessarily subject to risks and uncertainties that may cause future events to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ materially and adversely include Endologix’s ability to continue to follow-up on patients in the ENCORE analysis and to provide further ENCORE analyses. Undue reliance should not be placed upon the forward-looking statements contained in this press release, which speak only as of the date of this press release. Endologix undertakes no obligation to update any forward-looking statements contained in this press release 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 filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent Quarterly Reports on Form 10-Q, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.
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Contacts:
Endologix, Inc.
Vaseem Mahboob, CFO,
949-595-7200
