Noticias

Noticias

Endologix Announces Reinstatement of CE Mark for AFX® and AFX ® 2 Endovascular AAA System

  • Título: Endologix Announces Reinstatement of CE Mark for AFX® and AFX ® 2 Endovascular AAA System
  • Fecha: 25-01-2017
  • John McDermott, Chief Executive Officer of Endologix, said, "We are pleased that AFX and AFX2 are once again
    available to physicians and patients in Europe. The quick reinstatement of the CE Mark is a testament to the
    strong commercial clinical results achieved with the current generations of the device. Additionally, during this
    process we received numerous letters and endorsements from physicians worldwide and we'd like to thank them
    for their support."
    The CE Mark was temporarily suspended due to reports of Type III endoleaks with a prior generation of the AFX
    system. The CE Mark was reinstated based upon low rates of reported Type III endoleaks with the current
    generation of AFX products, which was also outlined in a recent
    letter to physicians
    provided by Endologix.
    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.
    Addi
    tional 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 availability for sale of AFX devices in the
    EU, 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, unexpected delays in process and testing improvements and
    additional regulatory requirements. 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.




  • Fuente: endovascular.es