IRVINE, Calif.--(BUSINESS WIRE)--
Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative
treatments for aortic disorders, announced today the completion of
enrollment in the Expanding Patient
Applicability with Polymer Sealing
Ovation Alto Stent
Graft (ELEVATE) IDE clinical study. The objective of the 75-patient
study is to evaluate the safety and effectiveness of the Alto Abdominal
Stent Graft System for the repair of infrarenal abdominal aortic
aneurysms (AAAs). The Company plans to file regulatory submissions in
the third quarter of 2018 and anticipates potential approval of the Alto
device in both the U.S. and European markets in 2019.
The study's principal investigator, Dr. Sean Lyden, Chairman of the
Department of Vascular Surgery at Cleveland Clinic, commented, "We are
pleased to complete enrollment of the ELEVATE IDE Trial and look forward
to evaluating the clinical results later this year. The Alto device
incorporates several design enhancements that are intended to simplify
the procedure and enable the system to treat a wider range of AAA
anatomies than Ovation iX."
Alto is the latest-generation Polymer EVAR system, which expands patient
applicability by moving the polymer sealing ring near the proximal edge
of the graft. The new device was designed based upon physician feedback
and the positive clinical results from the Ovation platform that has
been extensively studied in over 1,300 patients from five prospective
studies over the past seven years. Alto is an investigational device not
currently approved in any market, and its safety and effectiveness have
not been established.
John McDermott, Chief Executive Officer of Endologix, Inc., said,
"Enrollment of the ELEVATE IDE Trial is an important step in advancing
our portfolio of innovative technologies for aortic patients. I would
like to thank the physicians who have provided input into the Alto
device, as well as the clinical investigators and their teams for
participating in the study. We look forward to working with the global
regulatory agencies and making the Alto device available for physicians
and their patients as soon as possible."
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 progress and
results of Endologix's ELEVATE clinical study, Endologix's ability to
obtain regulatory approval of the Alto system within currently
anticipated timeframes, potential benefits of the Alto System, and
future commercial availability (and use) of the Alto 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 Alto system), 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 ELEVATE study), product research and development
efforts, uncertainty in the process of obtaining and maintaining U.S.
FDA and other regulatory approvals for the Alto device and other
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/20180205005132/en/
Vaseem Mahboob, CFO,
Source: Endologix, Inc.
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