Endologix Announces Positive Clinical Results from the LEOPARD Clinical Study
August 17 2017 - 8:00AM
Business Wire
Endologix, Inc. (NASDAQ:ELGX), a developer and marketer of
innovative treatments for aortic disorders, today announced
positive interim results from the LEOPARD (Looking
at Evar Outcomes
by Primary Analysis
of Randomized Data) clinical study. LEOPARD
is the first and only head-to-head, prospective, multi-center,
randomized clinical study comparing currently available
endovascular abdominal aortic stent grafts. LEOPARD directly
compares the Endologix AFX® and AFX2 endografts to other
commercially available bifurcated aortic endografts.
LEOPARD was initiated in 2015 and has since randomized 458
patients. The primary endpoint in the study is freedom from
Aneurysm Related Complications (“ARC”), such as aneurysm rupture,
conversion to open repair, endoleaks, migration, aneurysm
enlargement and secondary interventions. Based upon the patients
that have completed their one-year follow-up, freedom from ARC with
AFX/AFX2 is 84.7%, compared to 82.0% with the other devices. These
preliminary results demonstrate similar outcomes between the
endografts under investigation, but there is a trend towards better
performance for AFX/AFX2, which is the only device that preserves
the patient’s aortic bifurcation. Based upon the anticipated number
of additional patients required to prove superiority, Endologix
plans to stop further randomization in the LEOPARD study and
continue to follow enrolled patients for the planned five
years.
“The results from this analysis are very encouraging. In
particular, we are pleased with the trend towards lower rates of
endoleaks, limb occlusions and secondary interventions with
AFX/AFX2, along with the absence of Type 3 endoleaks,” commented
John McDermott, Endologix’s Chief Executive Officer. “We’d like to
thank our investigators for participating in this important
clinical study and look forward to presenting the final one-year
results next year after all patients have completed their
follow-up.”
About Endologix
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.
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,” ‘plan,’ “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 continuation of the LEOPARD study and presentation of further
results, the accuracy of which are necessarily subject to risks and
uncertainties that may cause future events 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 include Endologix’s ability to
continue to follow-up on patients in the LEOPARD trial. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170817005237/en/
Investors:Endologix, Inc.Vaseem Mahboob, 949-595-7200CFO
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