IRVINE, Calif.--(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
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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Source: Endologix, Inc.
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