Endologix Resumes Shipments of All Sizes of AFX®2 Endovascular AAA Systems
18 January 2017 - 2:29AM
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 QualityEndologix 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 III 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.
COMPANY CONTACT:
Endologix, Inc.
John McDermott, CEO
Vaseem Mahboob, CFO
(949) 595-7200
www.endologix.com
INVESTOR CONTACTS:
The Ruth Group
Zack Kubow (646) 536-7020
Nick Laudico (646) 536-7030
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