IRVINE, Calif.--(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 confirmatory clinical
study to evaluate the safety and effectiveness of the Nellix
EndoVascular Aneurysm Sealing System ("EVAS") for the endovascular
treatment of infrarenal abdominal aortic aneurysms. The EVAS2 IDE
Multicenter Safety and Effectiveness Confirmatory Study ("EVAS2") will
prospectively evaluate the refined Indications for Use (IFU) and the
Nellix Gen2 EVAS System. The study is approved to enroll up to 90
primary patients, with one-year follow-up data required for the
Pre-market Approval Application (PMA).
The Nellix EVAS 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.
John McDermott, Chief Executive Officer for Endologix, said, "We are
pleased to receive IDE approval from the FDA to begin this confirmatory
study and look forward to collaborating with the investigators to
achieve the goal of commencing enrollment by the end of this year. Based
on the anticipated enrollment timeline, one-year follow up period, and
regulatory review process, we continue to estimate PMA approval in 2020."
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.
The Nellix® EndoVascular Aneurysm Sealing System has obtained
CE Mark in the EU and is only approved as an investigational device in
the United States.
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 confirmatory clinical study
(including enrollment timeline), Endologix's ability to obtain
regulatory approval of the Nellix EVAS System within currently
anticipated timeframes, and future commercial availability of the Nellix
EVAS 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, continued market acceptance, endorsement and use of
Endologix's products (including market acceptance and adoption of the
Nellix EVAS System with its refined IFU), risks associated with the
manufacturing of Endologix's products, the success of clinical trials
relating to Endologix's products (including the clinical results of the
EVAS2 study), product research and development efforts, uncertainty in
the process of obtaining and maintaining U.S. FDA and other regulatory
approvals for Endologix's products, 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, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171006005129/en/
Vaseem Mahboob, 949-595-7200
Source: Endologix, Inc.
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