Endologix Provides Update on Previously Announced Voluntary Nellix System Recall
January 22 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
suspended by its Notified Body, GMED, following a voluntary recall
and Field Safety Notification (FSN) issued by Endologix on January
4, 2019.
“The notification from GMED is a regulatory action and is not in
response to any new information beyond our recent FSN,” said Dr.
Matt Thompson, Chief Medical Officer of Endologix. “This action is
consistent with our previously articulated plans for the Nellix
System and does not affect other Endologix products. We remain
steadfast in our commitment to patient safety and believe in the
transformational potential of Nellix.”
Earlier this month, Endologix announced that the Nellix System
will for the foreseeable future be made available only for use at
approved centers in a clinical investigation setting, with all
cases pre-screened by a physician panel and supported by Endologix
to ensure use in accordance with the current indications and
optimal clinical outcomes.
Suspension of the CE Mark means that Endologix may not affix the
CE Mark and sell the Nellix System in the European Union during the
term of the suspension.
Endologix does not expect this action 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: limited availability of the Nellix System in
the foreseeable future at approved centers in a clinical
investigation setting to ensure use in accordance with the current
indications and optimal clinical outcomes ; effect of the CE Mark
suspension, and; the expectation that the CE Mark suspension will
not impact Endologix’s previously communicated 2019 financial
guidance , 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, Endologix’s ability to continue to access the
capital markets on terms acceptable to it or at all, Endologix’s
ability to remain in compliance with its obligations to its
creditors and other counterparties, 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,
2017, and its Quarterly Reports on Form 10-Q for the quarters ended
March 31, 2018, June 30, 2018, and September 30,
2018 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/20190122005753/en/
Vaseem Mahboob(949) 595-7200
Endologix (NASDAQ:ELGX)
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