IRVINE, Calif., June 09, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today positive clinical data from the Italian Research Nellix Endoprosthesis (“IRENE”) study at the 2016 Society of Vascular Surgery (“SVS”) Annual Meeting. This retrospective, multicenter study was designed to evaluate the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") for the endovascular repair of infrarenal abdominal aortic aneurysms ("AAA").
The key highlights from the IRENE study clinical data include:
- 335 consecutive elective patients were enrolled at 16 centers throughout Italy between September 2013 and November 2015; 244 patients reached one year follow-up.
- 88% of the patients were treated within the device Instructions for Use ("IFU"), with 100% procedural technical success achieved.
- Low all-cause mortality of 0.9%
- 2.4% overall incident endoleak
- 0.9% limb occlusion
- 4.4% secondary interventions
- No ruptures; no migration
Bruno Gossetti, MD from the University of Rome La Sapienza, Rome, Italy, and Principal Investigator of the IRENE study, said, “We are very pleased with the initial procedural results and outcomes using Nellix in Italy in a wide range AAA anatomies in a non-selected population and within high IFU compliance. The low endoleak, graft occlusion, and AAA-related reintervention rates are very encouraging.” Fabio Verzini, MD, from the University of Perugia, Perugia, Italy and IRENE investigator presented these data at the SVS when he commented, “These data support the adoption of EVAS with Nellix in the real-world setting, including in patients who are more susceptible to Type II endoleaks.”
John McDermott, Chairman and Chief Executive Officer of Endologix, said, “We would like to thank the IRENE investigators for their clinical research and interest in EVAS with Nellix. The results from IRENE are consistent with the EVAS FORWARD Global Registry and the recently reported EVAS FORWARD IDE Study, demonstrating a low rate of endoleaks and secondary interventions in a large population of real-world AAA patients. We look forward to our continued collaboration with physicians worldwide to provide innovative and durable solutions for patients with AAA.”
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.
Positive clinical data on the Nellix EVAS System from the EVAS FORWARD-IDE Study was recently published in the schedule of the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which is taking place from June 8-11, 2016 in National Harbor, Maryland. Jeffrey P. Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for in a conference call and webcast hosted by Endologix at 1:00 pm ET that day. Dr. Carpenter is the National Principal Investigator of the EVAS FORWARD-IDE clinical study. The webcast will include presentation slides to accompany the prepared remarks, which will be followed by a question and answer session. The conference call will be available to interested parties through a live audio webcast at investor.endologix.com, where it will be archived and accessible for approximately 12 months. The live dial-in number for the call is 877-407-0789 (U.S.) or 201-689-8562 (International), which should be used by those interested in participating in the question and answer session. A telephonic replay of the call will be available from June 11, 2016 to June 18, 2016. The replay dial in numbers are 877-870-5176 (U.S.) or 858-384-5517 (International). The replay pin number is 13637957.
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. Additional information can be found on Endologix's website at 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 the clinical and commercial potential, and U.S. regulatory approval, of 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 outcomes and delays in the regulatory approval process. 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