Results Presented Today in Late-Breaking Aortic Trials Session at
Charing Cross International Symposium
IRVINE, Calif.--(BUSINESS WIRE)--
Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative
treatments for aortic disorders, today announced the results of a study,
which was presented by Marc Schermerhorn, M.D., Chief of Vascular
Surgery at Beth Israel Deaconess Medical Center, on the podium at the
Late-Breaking Aortic Trials Session during the Charing Cross (CX) 40th
International Symposium. This retrospective, propensity-weighted study
compares long-term survival for the Nellix® EndoVascular Aneurysm
Sealing (EVAS) System with traditional endovascular aneurysm repair
(EVAR). The study demonstrated significantly higher three-year survival
for EVAS patients. Those patients with larger aneurysms treated with
EVAS had half the mortality at three years as compared to those treated
with traditional EVAR systems.
The retrospective study included 333 EVAS patients from the original
Nellix U.S. Investigational Device Exemption (IDE) Trial and 15,431 EVAR
patients from the Society for Vascular Surgery Vascular Quality
Initiative (VQI), all of whom were treated between 2014 and 2016. The
patients were propensity weighted for abdominal aortic aneurysm (AAA)
size, patient demographics, and cardiovascular risk factors. The primary
outcome was overall survival, with a secondary analysis of overall
survival stratified by aneurysm size.
EVAS patients experienced higher three-year survival than EVAR patients
(93 percent versus 88 percent, P = .02), which corresponded to a
41-percent lower risk of mortality with EVAS. In patients with larger
aneurysms (greater than 5.5cm in diameter), patients treated with EVAS
had a mortality rate 50 percent lower than patients treated with EVAR (P
"The study sought to examine two different therapies for treating AAA
and compare the associated mortality. Traditional EVAR excludes the
aneurysm sac and has been associated with thrombus generation, sac
remodeling, inflammation, and endoleaks, while EVAS excludes and seals
the entire aneurysm sac," said Dr. Schermerhorn.
He continued, "The survival difference seen in this study supports the
continued development of EVAS therapy and demonstrates its potential to
improve patient outcomes. The results also justify further study to
compare cardiovascular events between the two therapies in order to
understand the mechanism behind the events."
Endologix's Chief Medical Officer, Matt Thompson, M.D., commented, "In
earlier Nellix EVAS studies, all-cause and cardiovascular mortality were
lower than expected, and this propensity-weighted analysis is the first
contemporary comparison of the data. We are committed to the innovative
aneurysm sealing approach and look forward to completing our EVAS2
confirmatory trial, which is required in support of FDA approval."
Since completion of the original 333-patient Nellix IDE trial, the
Instructions for Use (IFU) have been refined to improve aneurysm-related
outcomes. In March 2018, Endologix initiated the EVAS2 confirmatory IDE
trial to evaluate the safety and effectiveness of the refined IFU
together with the next generation Nellix EVAS System.
The data that serve as the basis for this analysis include patients
under the original Nellix IFU criteria, and the analysis has not been
reviewed by the FDA. The Nellix EndoVascular Aneurysm Sealing System is
an investigational device in the U.S. and is limited by federal law to
investigational use only. The Nellix EndoVascular Aneurysm Sealing
System and associated components are not available in all countries or
regions. In countries and regions in which it is approved, the Nellix
EndoVascular Aneurysm Sealing System is approved to treat infrarenal
abdominal aortic aneurysms and is not approved for any other intended
use in any geography. Prior to use, refer to the IFU for complete and
specific indications, contraindications, all warnings and precautions.
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 EVAS/EVAR comparison analysis
and presentation of further results, continued development of EVAS
therapy (and comparison as to EVAR), the potential of EVAS to improve
patient outcomes, and conduct and completion of the EVAS2 confirmatory
trial, 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 future availability and sufficiency of
data supporting the benefits of EVAS, and risks regarding conduct of the
EVAS and EVAS2 clinical trials (and other EVAS trials and studies) and
the results thereof. 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, 2017 and 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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Mahboob, CFO, 949-595-7200
Source: Endologix, Inc.
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