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Endologix Resumes Shipments of All Sizes of AFX®2 Endovascular AAA Systems

  • Título: Endologix Resumes Shipments of All Sizes of AFX®2 Endovascular AAA Systems
  • Fecha: 17-01-2017
  • Appoints Laura Nagel as Vice President, Global Quality

    IRVINE, Calif., Jan. 17, 2017 (GLOBE NEWSWIRE)
    -- Endologix, Inc. (Nasdaq: ELGX), developer and marketer of
    innovative treatments for aortic disorders, today announced that the company has resumed shipments of all sizes
    of AFX®2 Endovascular AAA Systems. The large diameter sizes of AFX2 were placed on a temporary hold
    December 27, 2016, to investigate a manufacturing issue. Since that time, the company has been working
    diligently on process improvements and developed additional rigorous testing protocols that have been reviewed
    by FDA. Shipments of the larger sizes of AFX2 will resume today.
    John McDermott, Chief Executive Officer of Endologix, said, "We are pleased that all sizes of AFX2 are once again
    available to physicians and patients. Following our review of additional testing protocols with FDA, we have
    released the remaining sizes of AFX2 from the voluntary shipping hold. We'd like to thank our customers
    worldwide for their support and patience over the past month and look forward to our continued collaboration in
    the treatment of patients with abdominal aortic aneurysms."
    Vice President, Global Quality
    Endologix also announced the appointment of Laura Nagel as Vice President, Global Quality, effective January 23,
    2017. Mr. McDermott commented, "Laura Nagel brings over 25 years of medical device experience, including
    specific experience with catheter-based technologies in Class II
    I cardiovascular devices. She has a great track
    record across all global quality functions, having successfully built and led high performing teams, developed and
    tested high quality implantable devices, and managed multiple manufacturing sites. She is also a very patient-
    focused leader whose values are a perfect fit for the team at Endologix."
    Most recently, Ms. Nagel served as Vice President, Quality Assurance at Direct Flow Medical, a privately-held
    medical device company developing and commercializing novel transcatheter heart valve products. From 1997 to
    2015, she served in several leadership positions at Edwards Lifesciences and has broad experience in quality
    assurance, design validation, quality engineering, microbiology, compliance and post-market surveillance. She
    also has extensive experience dealing with international regulatory agencies. Ms. Nagel began her career at
    Allergan, serving in regulatory affairs, project management and product development positions, from 1987 to
    1997. Ms. Nagel received a Bachelor's degree in biological science from the University of California, Berkeley.


    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 continued shipping of AFX products,
    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, unexpected delays in
    product manufacturing and testing 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