IRVINE, Calif., Nov. 18, 2015 (GLOBE NEWSWIRE) — Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the start of a physician-initiated registry of the Nellix® EndoVascular Aneurysm Sealing System (“Nellix EVAS System”) used with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms (“AAAs”). The registry, to be conducted outside of the United States, will be called the ASCEND Registry (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability). The primary investigators are Andrew Holden, MD, Associate Professor of Radiology at Auckland Hospital; and Professor Matthew Thompson, MD, Professor of Vascular Surgery, St. Georges Vascular Institute, London. The Nellix System received CE Mark in 2013 for the treatment of patients with infrarenal AAAs. The Nellix System is an investigational device in the United States.
Professor Thompson said, “Given our positive initial experience utilizing Nellix with aortic branch stent grafts for the treatment of complex AAAs, we look forward to initiating the ASCEND Registry to evaluate the use of EVAS to treat this patient population. Complex AAAs represent more than one-third of patients with abdominal aneurysms, and the management of these patients remains difficult. Treatment options include open surgical treatment, which has a high rate of mortality and morbidity, and custom-made endovascular devices, which are technically challenging and only address a limited proportion of patients with complex aneurysms. Similar to utilizing Nellix for infrarenal AAA cases, Nellix with aortic branch stent grafts has the potential to address a wide range of patients with complex aortic morphologies that are unsuitable for both EVAR and open surgical repair.”
The ASCEND Registry will enroll 200 patients with complex AAAs at up to 10 international centers. The complex anatomies include juxta-renal (aneurysm extends up to renal arteries) and para-renal (aneurysm includes renal arteries) AAAs. It will be an open-label, single-arm, observational real-world registry with no prospective screening. The endpoints of the ASCEND Registry include overall and aneurysm related mortality, major adverse events, endoleak and secondary intervention rates, Nellix and aortic branch stent graft patency, renal function and durability.
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire aneurysm sac. It is the first and only EVAS product and was developed to mitigate all types of endoleaks, improve stability and long-term patient outcomes.
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.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to enrollment in and results of the ASCEND study and the ability of the Nellix EVAS System to treat a broader range of patients , 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 lack of physician or patient participation and unanticipated clinical outcomes. 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, 2014, 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.
CONTACT: 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
