Endologix Announces Reinstatement of CE Mark for its Nellix EndoVascular Aneurysm Sealing System
June 06 2019 - 4:01PM
Business Wire
Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of
innovative treatments for aortic disorders, announced today that
the EC Certificate of Conformity (CE Mark) for the Nellix
EndoVascular Aneurysm Sealing System (Nellix System) has been
reinstated by GMED, the EU Notified Body for the Nellix System. The
reinstatement followed an assessment of clinical evidence.
“We continue to believe that the Nellix System has the potential
to transform the treatment of patients with infra-renal abdominal
aortic aneurysms,” said Matt Thompson MD, Chief Medical Officer of
Endologix, Inc. “This therapy continues to generate positive
results when used in patients that conform to the anatomical
indications for use. We are delighted that the available data
supports the reinstatement of our CE mark, and we look forward to
utilizing this technology to improve the patient experience and
drive better outcomes.”
As previously disclosed, the Nellix System will be made
available for use at approved centers in a post-market clinical
investigational setting outside the USA. Within the USA, the Nellix
System remains an investigational device as part of the EVAS2
study.
The Company does not expect this reinstatement to impact its
previously communicated financial guidance for 2019.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally
invasive treatments for aortic disorders. The Company's focus is in
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 an 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 U.S. For more information,
visit www.endologix.com.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements generally can be identified by the use
of words such as “anticipate,” “expect,” “could,” “may,” “will,”
“believe,” “estimate,” “forecast,” “goal,” “project,” "continue,"
"outlook," “guidance,” "future,” other words of similar meaning and
the use of future dates. Forward-looking statements used in this
press release include: Endologix’s plan to have the Nellix System
be made available only for use at approved centers in a clinical
investigation setting outside the United States; use of Nellix
System to improve the patient experience and drive better outcomes;
and Endologix’s statement that it does not expect the reinstatement
to impact previously communicated financial guidance for 2019 , the
accuracy of which are necessarily subject to risks and
uncertainties that may cause Endologix’s actual results to differ
materially and adversely from the statements contained herein. Some
of the potential risks and uncertainties that could cause actual
results to differ materially and adversely from anticipated results
include, continued market acceptance, endorsement and use of
Endologix's products, the success of clinical trials relating to
Endologix’s Nellix System and other products, product research and
development efforts, uncertainty in the process of obtaining and
maintaining regulatory approval for Endologix's products including
its CE Marking and similar regulatory clearances, Endologix’s
ability to continue to access the capital markets, Endologix’s
ability to protect its intellectual property rights and proprietary
technologies, and other economic, business, competitive and
regulatory factors. The forward-looking statements contained in
this press release speak only as of the date of this press release.
Endologix undertakes no obligation to update any forward-looking
statements contained in this press release 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 filings with the Securities and Exchange Commission
including its Annual Report on Form 10-K for the year ended
December 31, 2018, and its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2019 for more detailed information
regarding these risks and uncertainties and other factors that may
cause actual results to differ materially from those expressed or
implied.
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version on businesswire.com: https://www.businesswire.com/news/home/20190606005767/en/
Vaseem Mahboob(949) 595-7200
Endologix (NASDAQ:ELGX)
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