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Título: Endologix Receives Australian Therapeutic Goods Administration (TGA) Approval for AFX®2 Bifurcated Endograft System
Fecha: 19-12-2016
IRVINE, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the Australian Therapeutic Goods Administration (TGA) has approved the AFX®2 Bifurcated Endograft System for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of AFX2 for the treatment of abdominal aortic aneurysms (AAAs).
Vikram Puttaswamy, MD, vascular surgeon at Sydney Vascular Surgery in Sydney, Australia, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients. AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.”
AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal™ technology and DuraPly™ ePTFE graft material into an integrated new EVAR system.
John McDermott, Chief Executive Officer of Endologix, said, “The original concept of anatomical fixation was first introduced in 1999 and has been used to treat over 75,000 patients worldwide with AAA. Over the years we have collaborated with physicians to make design improvements and procedural enhancements to treat more patients more effectively. The latest version of the device, AFX2, was designed to incorporate 17 years of clinical experience together with rigorous testing to provide physicians and their patients with excellent long-term clinical outcomes.”
Mr. McDermott added, “The TGA approval of AFX2 in Australia will allow us to begin offering the latest version of our unique anatomical fixation system to physicians and patients beginning in 2017. It also provides additional third party support on the safety and efficacy of the AFX2 system, reinforcing the positive clinical results we have seen with AFX and AFX2 since launching the system in other parts of the world earlier this year.”
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. Additional information can be found on Endologix's website at www.endologix.com.
Forward-Looking Statements
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 benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 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 delays in the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system. 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
Fuente: endovascular.es

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