Endologix Receives FDA Approval for Alto Abdominal Stent Graft System
March 16 2020 - 9:00AM
Business Wire
Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a
developer and marketer of innovative treatments for aortic
disorders, today announced that it has received approval from the
United States Food and Drug Administration (FDA) for the Alto™
Abdominal Stent Graft System (Alto).
The Company received approval based on its regulatory submission
that includes the ELEVATE Investigational Device Exemption (IDE)
clinical study. Pursuant to the terms of approval, the first 100
patients after commercial launch will be included in a post
approval imaging study to determine consistency in device selection
between Endologix’s internal imaging services and those of the
implanting physicians.
“We are thrilled to receive approval for the Alto system,”
commented Matt Thompson, Chief Medical Officer of Endologix. “We
have worked collaboratively with the FDA throughout the Alto
premarket approval (PMA) process, and we will be carefully
monitoring intra-procedural events as Alto ramps to full
commercialization. We anticipate observing improved short-term
outcomes relative to the Ovation iX Abdominal Stent Graft System
(Ovation iX) as a result of the design and manufacturing changes
incorporated into Alto. However, as we expect Ovation iX to remain
commercially available for a period of time subsequent to the Alto
launch, we will also be updating our previous 2018 safety
communication as it relates to the Ovation iX system.”
“Alto approval is a critical landmark for Endologix as we seek
to introduce a portfolio of devices to address the current unmet
needs of endovascular aneurysm repair (EVAR),” commented John
Onopchenko, Chief Executive Officer of Endologix. “Alto is a
differentiated EVAR device that offers significant design features
that we believe will enhance ease of use, improve acute outcomes,
and preserve the long-term durability associated with
patient-specific anatomically adaptive sealing. We believe Alto’s
ultra-low profile and its 7mm aortic neck length indication give it
the broadest applicability of any endograft in the U.S. We are
committed to proving the superiority of this product over
traditional undifferentiated EVAR grafts in a randomized clinical
trial, while remaining steadfastly focused on re-establishing
durable, predictable growth through a continued focus on execution
and evidence-driven differentiation.”
About Endologix, Inc.
Endologix 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 an 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 statements regarding: Endologix’s performance
of a 100-patient imaging study per the terms of FDA’s approval;
monitoring of intra-procedural events; anticipated observation of
improved short-term outcomes for Alto as relative to the Ovation iX
system; anticipated updates to Endologix’s previous 2018 safety
communication as it relates to the Ovation iX system; perceived
benefits of Endologix’s Alto product; Endologix’s intent to prove
the superiority of Alto over traditional undifferentiated EVAR
grafts in a randomized clinical trial; and Endologix’s ability to
re-establish durable, predictable growth, the accuracy of each 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,
continued market acceptance, endorsement and use of Endologix's
products, the success of clinical trials relating to Endologix’s
Alto system and other products, timing and success of clinical
trial enrollment and completion, product research and development
efforts, uncertainty in the process of obtaining and maintaining
regulatory approval for Endologix's products, Endologix’s ability
to comply with and discharge its obligations under its debt
agreements with its secured lenders, Endologix’s ability to
continue to access the capital markets and to otherwise procure
capital necessary to fund its business as needed, Endologix’s
ability to protect its intellectual property rights and proprietary
technologies, and other economic, business, competitive and
regulatory factors. The forward-looking statements contained in
this press release 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. Although we
believe that the forward-looking statements contained herein are
reasonable, we can give no assurance that our expectations are
correct.
All forward-looking statements are expressly qualified in their
entirety by this cautionary statement. 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, 2019,
and its 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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INVESTOR: Endologix, Inc. Vaseem Mahboob, CFO (949) 595-7200
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