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Endologix Announces FDA Approval of AFX™ Endovascular AAA System

IRVINE, Calif., June 15, 2011 /PRNewswire/ -- Endologix, Inc. (Nasdaq: ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its next generation product, the AFX™ Endovascular AAA System, for the treatment of abdominal aortic aneurysms (AAA).  Endologix is introducing AFX at the Annual Meeting of the Society for Vascular Surgery (SVS), which is taking place June 16-18, 2011 in Chicago, IL.  

AFX builds upon Endologix's clinically proven anatomical fixation technology with  a new low profile, highly precise delivery system and a state of the art, proprietary stent graft material (STRATA™).  The key features of the AFX System include:

  • Low profile 17Fr introducer sheath – The entire family of AFX stent grafts, which range in diameter from 13 to 34 millimeters, are delivered through a low profile, hydrophilically-coated 17Fr  introducer sheath – obviating the need for exchanges. Notably, this sheath technology, combined with the System's percutaneous (9Fr) contralateral access, makes AFX the lowest profile device approved in the U.S. for the treatment of the most common AAAs – those with aortic neck diameters of 22 millimeters or larger.
  • Precise delivery and deployment – The AFX delivery system features an ergonomic dial mechanism that provides physicians with precise, controlled stent graft positioning and deployment.  These features were designed with significant input from endovascular specialists globally.  
  • STRATA expanded polytetrafluoroethylene (ePTFE) graft – AFX stent grafts are constructed using Endologix's proprietary new STRATA graft material. STRATA is a durable, highly conformable material featuring enhanced stent graft sealing technology.

  • John McDermott, President and Chief Executive Officer of Endologix, commented, "Achieving FDA approval for the AFX System is an important milestone for Endologix and for the physicians and patients we serve. The advances incorporated into the AFX System will give physicians even more confidence and precision in treating a wide range of AAA anatomies. The SVS annual meeting provides an ideal venue to begin educating physicians on the new system, which we expect to be commercially available within a couple of months following the necessary sales force training and inventory build."

    In addition to AFX, the Company's complete product portfolio will be highlighted at the SVS Annual Meeting.  This includes the investigational Nellix® Endovascular System and the Ventana™ Fenestrated Stent Graft System, both of which will be featured in symposia at SVS.

    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 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's Web site at  

    Forward-Looking Statements Except for historical information contained herein, this news release contains forward-looking statements, 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 the uncertainties related to the introduction and clinical acceptance of new products,. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and the Company's other 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:

    INVESTOR CONTACTS:Endologix, Inc.

    The Ruth GroupJohn McDermott, CEO

    Nick Laudico (646) 536-7030(949) 595-7200

    Zack Kubow (646)

    SOURCE Endologix, Inc.
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