IRVINE, Calif.--(BUSINESS WIRE)--
Endologix, Inc. (NASDAQ: ELGX), a developer and marketer of innovative
treatments for aortic disorders, today announced the CE Mark approval
for its Nellix® EndoVascular Aneurysm Sealing System
("Nellix") with the refined Indications for Use (IFU). Nellix is being
studied in the U.S. under an Investigational Device Exemption (IDE).
Following a thorough review of supporting clinical data, the Company's
notified body, together with an independent clinical reviewer, has
determined that Nellix, with the refined IFU, meets the applicable
safety and clinical performance requirements. As a result of these
evaluations, the notified body has granted a CE Mark for Nellix with the
"We are very pleased with the clinical outcomes generated by the Nellix
EndoVascular Aneurysm Sealing System utilizing the refined IFU,"
commented John McDermott, Endologix's Chief Executive Officer. "The
Nellix CE Mark with the refined IFU provides patients and physicians in
Europe with continued access to the clinical benefits of complete
aneurysm sealing, including low rates of endoleaks and all-cause
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 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, but are
not limited to, statements regarding continued access to, and benefits
of, certain of Endologix's existing products and potential future
products, 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
uncertainty in the process of obtaining regulatory approvals for
Endologix's products, continued market acceptance, endorsement and use
of Endologix's products, the success of Endologix's product development
and quality assurance efforts, the success of clinical trials relating
to Endologix's products, product research and development efforts, risks
associated with obtaining third party payer reimbursement, Endologix's
ability to compete on price and quality, risks associated with
international operations including currency exchange rate fluctuations,
Endologix's ability to protect its intellectual property rights and
proprietary technologies, and other economic, business, competitive and
regulatory factors. Undue reliance should not be placed upon the
forward-looking statements contained in this press release, which 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 filings on Form 10-K and 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.
1 Carpenter, J.P. (2017, June). Nellix System for
Endovascular Aneurysm Sealing: Effect of IFU Refinements on Outcomes
from the EVAS FORWARD IDE. Presented at the 2017 Vascular Annual
Meeting, San Diego, CA.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170921005389/en/
Vaseem Mahboob, 949-595-7200
Source: Endologix, Inc.
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