Endologix, Inc. Announces Enrollment of the First Patient in EVAS2 IDE Clinical Study of the Nellix® EndoVascular Aneurysm S...
March 05 2018 - 8:00AM
Business Wire
Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of
innovative treatments for aortic disorders, announced today that
the first patient was treated in the EVAS2 IDE Confirmatory
Clinical Study of the investigational Nellix® EndoVascular Aneurysm
Sealing (EVAS) System by Sajjad M. Hussain, M.D., Chief of the
Department of Vascular Surgery at St. Vincent Health and St.
Vincent Heart Center of Indiana.
The Nellix System is an endovascular abdominal aortic aneurysm
(AAA) therapy designed to seal the entire aneurysm. Nellix is the
first and only EVAS product developed as an alternative treatment
approach to traditional EVAR devices. The Nellix System has
received a CE Mark and is commercially available in many markets,
including the EU.
EVAS2 is an IDE-approved confirmatory clinical study, which is
designed to evaluate the safety and effectiveness of the
second-generation Nellix System and the refined Indications for Use
(IFU). The study is approved to enroll up to 90 primary patients at
28 U.S. centers, with one-year follow-up data required for the
Pre-Market Approval (PMA) application.
“We are excited to be part of this important trial studying the
concept of total aneurysm sealing,” said Jeffrey Carpenter, M.D.,
Professor and Chairman of Surgery for Cooper Medical School,
Chief of Surgery for Cooper Health System in New
Jersey, and principal investigator for the EVAS2 study. “The
second-generation Nellix device, together with the refined IFU and
our clinical learnings over the past few years, has the potential
to improve outcomes for patients with abdominal aortic
aneurysms.”
John McDermott, Chief Executive Officer of Endologix, Inc.
said, "We would like to congratulate Dr. Hussain and the clinical
study team at St. Vincent Hospital for completing the first EVAS2
procedure in the confirmatory study. We look forward to
collaborating with all of our investigators to achieve excellent
clinical outcomes for patients and to complete enrollment in the
study. Based on anticipated enrollment, follow-up, and typical
regulatory review timelines, we continue to estimate a decision on
our PMA by the end of 2020.”
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. 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
the anticipated enrollment, progress and results of Endologix’s
EVAS2 clinical study, Endologix’s ability to obtain regulatory
approval of the Nellix System within currently anticipated
timeframes, and potential benefits of the Nellix System, 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 Endologix’s ability to continue integrating the businesses
and operations of, and to realize the expected benefits of its
merger with, TriVascular, market acceptance, endorsement and use of
Endologix's products (including market acceptance and adoption of
the Nellix System), risks associated with the manufacturing of
Endologix’s products, the success of clinical trials relating to
Endologix’s products (including successful enrollment of, and the
clinical results generated by, the EVAS2 clinical study), product
research and development efforts, uncertainty in the process of
obtaining and maintaining U.S. FDA and other regulatory approvals
for the Nellix System on currently anticipated timelines or at all,
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 Annual Report on Form 10-K for
the year ended December 31, 2016 and 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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Investors:Endologix, Inc.Vaseem Mahboob,
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