IRVINE, Calif.–(BUSINESS WIRE)– Endologix Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today the completion of enrollment in the Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft (ELEVATE) IDE clinical study. The objective of the 75-patient study is to evaluate the safety and effectiveness of the Alto Abdominal Stent Graft System for the repair of infrarenal abdominal aortic aneurysms (AAAs). The Company plans to file regulatory submissions in the third quarter of 2018 and anticipates potential approval of the Alto device in both the U.S. and European markets in 2019.
The study’s principal investigator, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic, commented, “We are pleased to complete enrollment of the ELEVATE IDE Trial and look forward to evaluating the clinical results later this year. The Alto device incorporates several design enhancements that are intended to simplify the procedure and enable the system to treat a wider range of AAA anatomies than Ovation iX.”
Alto is the latest-generation Polymer EVAR system, which expands patient applicability by moving the polymer sealing ring near the proximal edge of the graft. The new device was designed based upon physician feedback and the positive clinical results from the Ovation platform that has been extensively studied in over 1,300 patients from five prospective studies over the past seven years. Alto is an investigational device not currently approved in any market, and its safety and effectiveness have not been established.
John McDermott, Chief Executive Officer of Endologix, Inc., said, “Enrollment of the ELEVATE IDE Trial is an important step in advancing our portfolio of innovative technologies for aortic patients. I would like to thank the physicians who have provided input into the Alto device, as well as the clinical investigators and their teams for participating in the study. We look forward to working with the global regulatory agencies and making the Alto device available for physicians and their patients as soon as possible.”
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 anticipated progress and results of Endologix’s ELEVATE clinical study, Endologix’s ability to obtain regulatory approval of the Alto system within currently anticipated timeframes, potential benefits of the Alto System, and future commercial availability (and use) of the Alto system, the accuracy of which are necessarily subject to risks and uncertainties that may cause Endologix’s actual results 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 from anticipated results include Endologix’s ability to continue integrating the businesses and operations of, and to realize the expected benefits of its merger with, TriVascular, continued market acceptance, endorsement and use of Endologix’s products (including market acceptance and adoption of the Alto system), risks associated with the manufacturing of Endologix’s products, the success of clinical trials relating to Endologix’s products (including the clinical results of the ELEVATE study), product research and development efforts, uncertainty in the process of obtaining and maintaining U.S. FDA and other regulatory approvals for the Alto device and other Endologix’s products, risks associated with international operations, including currency exchange rate fluctuations, Endologix’s ability to protect its intellectual property rights and proprietary technologies, and other economic, business, competitive and regulatory factors. 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, 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.
Vaseem Mahboob, CFO, 949-595-7200
Source: Endologix, Inc.