Endologix Takes Decisive Action to Optimize Patient Outcomes by Ensuring Nellix System Used Only within Current Indications
January 04 2019 - 8:30AM
Business Wire
Voluntary Recall of Existing Inventory, New
Cases Conducted Under Clinical Protocol, and Patient Selection
Pre-Approved by Physician Panel
Decision Aligns with European Society for
Vascular Surgery Practice Guidelines
No Change to Previously Issued Revenue Guidance
for 2019
No Change to EVAS2 IDE
Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a
developer and marketer of innovative treatments for aortic
disorders, announced today that in order to ensure optimal outcomes
for patients, unrestricted sales and use of the Nellix System will
cease immediately, and the product will only be available for use
under clinical protocol with pre-screened patients that adhere to
the current indications.
“We monitor the performance of the Nellix System through
clinical trials, our complaint monitoring system, physician
interaction and available publications,” said Dr. Matt Thompson,
Chief Medical Officer of Endologix. “Our independently adjudicated
data from the EVAS1 IDE clinical trial indicates that the Nellix
System has performed well when used consistent with the current
indications. However, data from recent Nellix publications leave us
concerned that outcomes are suboptimal when the system is used
outside current instructions for use.”
To ensure optimal clinical outcomes, the Nellix System will, for
the foreseeable future, only be available for use under clinical
protocol with pre-screened patients that adhere to the current
indications. All cases will be pre-screened by a physician panel
and supported by Endologix clinical specialists to ensure adherence
to protocol. Compassionate use requests will be reviewed in
accordance with the process established by the Company and
associated national competent authorities. The existing inventory
will be voluntarily recalled. These actions are described in a
Field Safety Notification (FSN) issued today.
“Ensuring patient safety and optimal clinical outcomes is our
top priority, and the current level of off-label use of the Nellix
System cannot continue if we are to protect and preserve the
potential for transformative EndoVascular Aneurysm Sealing (EVAS)
therapy,” said John Onopchenko, Chief Executive Officer of
Endologix. “Taking these actions aligns with clinical practice
standards, allows us to control off-label use and will help us
ensure appropriate application of the therapy.”
This decision is one of several actions taken by Endologix
following a new management mandate in August 2018 to ensure the
most appropriate use of each of its devices and is in alignment
with a recent publication by the European Society for Vascular
Surgery (ESVS). Endologix has been in contact with regulatory
authorities regarding the Nellix System recall and related matters
to help ensure patient safety and continued appropriate access to
the Nellix System.
Endologix refined the technical procedure of EVAS and
voluntarily and proactively delivered clinical practice updates and
advisories regarding use of the Nellix System through a series of
FSNs developed in collaboration with regulatory authorities
worldwide. Nevertheless, Endologix has determined that off-label
use is occurring at an unacceptable level, with the consequence of
sub-optimal results. The Company is taking action to ensure optimal
outcomes for patients.
EVAS therapy was designed to overcome the durability issues of
conventional EndoVascular Aneurysm Repair (EVAR) that have led to
high rates of aneurysm related mortality when compared with
surgical interventions. “When used as indicated, EVAS is associated
with low rates of aneurysm sac growth, Type 2 endoleaks and
all-cause mortality,” said Mr. Onopchenko. “Our actions are
intended to preserve and advance this therapy. Clinical data drives
our decision making and is our basis for competing in the
marketplace. Limiting the use of the Nellix System to only those
cases rigorously adjudicated by a review board and performed under
clinical protocol will ensure that high integrity data is generated
and will enable us to deliver on the promise of this potentially
disruptive therapy.”
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally
invasive treatments for aortic disorders. The Company's focus is in
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: Endologix’s plan to have the Nellix System
be made available only for only for use under clinical protocol
with pre-screened patients that adhere to the current indications;
voluntary recall of existing Nellix inventory; intended
pre-screening and case support process for future Nellix cases ;
compassionate use of the Nellix System; controlling off-label use
and building data for on-label use; ensuring high integrity data
regarding the Nellix System; and enabling Endologix to deliver on
the promise of this potentially disruptive EVAS therapy , 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, continued market acceptance, endorsement and use of
Endologix's products, the success of clinical trials relating to
Endologix’s Nellix System and other products, product research and
development efforts, uncertainty in the process of obtaining and
maintaining regulatory approval for Endologix's products including
its CE Marking and similar regulatory clearances, Endologix’s
ability to continue to access the capital markets, 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. 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, 2017, and its Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2018, June 30, 2018, and
September 30, 2018 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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Vaseem Mahboob(949) 595-7200
Endologix (NASDAQ:ELGX)
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