IRVINE, Calif.--(BUSINESS WIRE)--Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced the presentation of two-year clinical data from the Company's Nellix® EVAS FORWARD IDE trial that prospectively enrolled patients with abdominal aortic aneurysms (“AAA”) who were treated with the Nellix® Endovascular Aneurysm Sealing System (“Nellix EVAS System”). The Study’s Principal Investigator, Dr. Jeffrey Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, presented the results at the Society of Vascular Surgery 2017 Vascular Annual Meeting.
Key highlights from the two-year data included:
- Freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%), among all patients.
- Highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients.
- When applying the refined IFUs for Nellix, patients at the two-year follow-up demonstrated a highly encouraging 96% freedom from Type Ia endoleak, migration, and sac growth.
Dr. Jeffrey Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, said, “The overall two-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent patient outcomes, and we look forward to validating these results in the upcoming prospective confirmatory study.”
John McDermott, Chief Executive Officer of Endologix, Inc., commented, “We would like to thank Dr. Carpenter and all the investigators for their participation in the IDE study, as well as their important contributions to the learning and evolution of EVAS. We have identified an AAA patient population that will significantly benefit from the Nellix device, and we look forward to expanding applicability with ChEVAS, and our next generation EVAS platform, in the future.”
The Company will host an investor call today at 12:00 p.m. PT (3:00 p.m. ET) to review the presentation.
To participate in the conference call, dial 888-283-6901 (domestic) or 719-457-2552 (international).
This 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 3:00 p.m. PT (6:00 p.m. ET) on Saturday, June 3, 2017, until 8:59 p.m. PT (11:59 p.m. ET) on Saturday, June 10, 2017. To hear this recording, dial 844-512-2921 (domestic) or 412-317-6671 (international) and enter the passcode 7744943.
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.
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 projected patient outcomes, enrollment and results of future clinical trials and the development of ChEVAS and the next generation EVAS platform, 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, the timing and results of clinical trials, uncertainties in regulatory actions and timing, and additional regulatory requirements. 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, 2016, 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.