IRVINE, Calif., Aug. 17, 2016 (GLOBE NEWSWIRE) --
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the first two patients with abdominal aortic aneurysms (“AAA”) have been treated with the Ovation Alto™ Abdominal Stent Graft System. The patients were treated by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital, Auckland, New Zealand.
Dr. Holden commented, “The repositioned sealing ring in the Ovation Alto system expands the EVAR treatment of AAA patients to include short and challenging aortic necks, which represents a significant segment of the underserved complex AAA market. We are pleased to be the first center in the world to implant Ovation Alto and look forward to treating more patients and sharing our experience with the clinical community.”
Dr. Hill said, “The Ovation Alto system has the potential to increase the number of AAA patients treated with EVAR due to its unique sealing technology and ultra-low profile design. The new system is designed to provide the broadest indications of all infrarenal EVAR devices, which represents an important advancement for physicians and their AAA patients.”
Ovation Alto is the newest device in the Ovation® platform of abdominal stent graft systems, which has excellent clinical results reported from the Ovation global pivotal trial and a 501-patient European Post-Market Registry. Ovation Alto expands EVAR to include the treatment of patients with complex AAAs, specifically patients with very short or otherwise challenging aortic neck anatomy. This is achieved by the conformable O-rings with CustomSeal™ polymer that have been repositioned near the top of the endograft, providing seal just below the renal arteries. The Ovation platform is the lowest profile FDA-approved EVAR device and has been used successfully in the treatment of approximately 10,000 patients worldwide. Ovation Alto is an investigational device and currently not approved in any market. It is expected to be introduced into Europe in 2017 and the U.S. in 2018.
Bob Mitchell, President of Endologix, said, “The first patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a wide range of anatomies, including the underserved complex AAA market. We would like to thank Dr. Holden and Dr. Hill for their collaboration in the first patients treated with the Ovation Alto system.”
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 regulatory approval, of the Ovation Alto 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 clinical trials and 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