Endologix Receives IDE Approval for the Nellix Chimney EndoVascular Aneurysm Sealing Protocol
August 08 2019 - 4:03PM
Business Wire
Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of
innovative treatments for aortic disorders, announced today that it
has received Investigational Device Exemption ("IDE") approval from
the United States Food and Drug Administration ("FDA") to commence
a new pivotal study to evaluate the safety and effectiveness of the
Nellix Chimney EndoVascular Aneurysm Sealing System ("ChEVAS") for
the endovascular treatment of complex abdominal aortic aneurysms
(“AAA”).
The ChEVAS system is an endovascular abdominal aortic aneurysm
therapy designed to combine the Nellix 3.5 endograft with parallel
visceral stents to enable treatment of patients with juxta-renal,
para-renal, and suprarenal AAA. The application of endovascular
aneurysm sealing (“EVAS”) for patients with complex aneurysms will
offer innovative new technology to a group of patients that are
underserved by the current standard of care.
John Onopchenko, Chief Executive Officer for Endologix,
commented, "We are pleased to receive IDE approval from the FDA to
begin this study, which will recruit 120 patients with complex AAA
in up to 50 centers, both in the USA and internationally. This
approval marks another step forward on our path to re-establishing
durable, predictable growth through a continued focus on execution
and evidence-driven differentiation."
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: potential benefits of CHEVAS to patients;
conduct of the CHEVAS IDE trial, and; Endologix’s reestablishment
of durable, predictable growth through a continued focus on
execution and evidence-driven differentiation , 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
CHEVAS system and other products, timing and success of clinical
trial enrollment and completion, 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, 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 subsequent Quarterly Reports on Form
10-Q 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/20190808005608/en/
Investors: Endologix, Inc. Vaseem Mahboob, CFO (949)
595-7200
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