Navigation Links
Endologix Announces FDA Approval of AFX™ Endovascular AAA System
Date:6/15/2011

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 www.endologix.com.  

    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) 536-7020www.endologix.com
    '/>"/>

    SOURCE Endologix, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Endologix Comments on Alleged Patent Infringement
    2. Endologix Responds to Alleged Patent Infringement
    3. Endologix to Report Third Quarter 2009 Financial Results on October 27, 2009
    4. Endologix Reports 47% Third Quarter 2009 Revenue Growth
    5. Endologix Files Motion to Discontinue Court Proceedings Related to Alleged Patent Infringement
    6. Endologix Enters Development Agreement and Exclusive License for Balloon Expandable Stent Technology
    7. Endologix Receives CE Mark Approval for Expanded Line of Powerlink Products and PowerFit Aortic Extensions
    8. Endologix to Report Third Quarter 2010 Financial Results on October 27, 2010
    9. Endologix Announces Publication of Clinical Trial Results Supporting Anatomical Fixation with a Suprarenal Aortic Extension
    10. Endologix to Present at Oppenheimer 21st Annual Healthcare Conference
    11. Endologix Reports 30% Third Quarter 2010 Revenue Growth
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/24/2017)... Research and Markets has announced the addition of the "Global ... report to their offering. ... The Global Empty Capsules Market is poised to grow at a CAGR ... by 2025. This industry report analyzes the market estimates ... regional levels presented in the research scope. The study provides historical market ...
    (Date:2/24/2017)... , Feb. 24, 2017  In conjunction with ... 2016 financial results press release, you are invited to ... live over the internet on Tuesday, March 14, 2017 ... A live audio webcast of the presentation ... www.durect.com and clicking "Investor Relations."  If you are ...
    (Date:2/24/2017)... Feb. 23, 2017 Report analyzes the worldwide markets ... comprehensive analytics for the US, Canada , ... Asia-Pacific , Latin America ... provided for the period 2015 through 2022. Also, a six-year ... analytics are derived from primary and secondary research. Company profiles ...
    Breaking Medicine Technology:
    (Date:2/24/2017)... ... February 24, 2017 , ... The narrative in “ Signal 8: An Australian ... account of his paramedic experiences. Schanssema describes the tragedies he saw, as well as ... overcome them. , Schanssema, initially unsure of the career path he wanted to take, ...
    (Date:2/24/2017)... ... , ... The International Association of Eating Disorders Professionals (iaedp) announces the 2017 ... image mannequin art competition. Selected from 15 submissions from around the nation, the top ... 31st annual iaedp Symposium, March 22 – 26 in Las Vegas. , This year, ...
    (Date:2/24/2017)... ... February 24, 2017 , ... Congratulations ... International Elite division on February 12th. Ms. Esparza qualified into this prestigious ... qualifier competition held in Las Vegas, Nevada. Frida is one of approximately 25 ...
    (Date:2/23/2017)... ... February 23, 2017 , ... The 89th Academy Awards will be celebrated ... National Education Policy Center Bunkum Award. We invite you to enjoy our 11th annual ... Bunkum winner is the Center for American Progress (CAP), for its report, Lessons From ...
    (Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss surgeon Michael Feiz, ... June: From Not to Hot,” which will begin airing on February 24, 2017. The ... millions from the 2012 reality television series, “Here Comes Honey Boo Boo.” The earlier ...
    Breaking Medicine News(10 mins):