Presented in Late-Breaking Session at the
Society for Vascular Surgery Annual Meeting
Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of
innovative treatments for aortic disorders, announced 1-year
results from the LUCY (Evaluation of FemaLes who
are Underrepresented Candidates for
Abdominal Aortic AneurYsm Repair) registry as reported on
Saturday, June 23rd at the 2018 Society for Vascular Surgery Annual
Meeting. The LUCY study is the first to prospectively evaluate
endovascular aneurysm repair (EVAR) outcomes in women who have more
complex aortic anatomy and, subsequently, have worse reported
outcomes than men undergoing EVAR.1 The results of the LUCY 1-year
data expand on the 30-day results presented last year, showing that
at least 28% more women are eligible for minimally-invasive EVAR
when using the Ovation Abdominal Stent Graft System than when using
other EVAR systems.2
The LUCY study is a prospective, consecutively enrolling,
non-randomized, multi-center, post-market registry evaluating the
Ovation System for the endovascular treatment of abdominal aortic
aneurysms (AAA) in women.3 The study enrolled a total of 225
patients, including 76 females in the treatment group and 149 males
in the control group, at 39 sites in the U.S. The primary endpoint
of the study was the 30-day Major Adverse Event ("MAE") rate and
secondary endpoints including serious and non-serious adverse
events through one year.
The 1-year LUCY data showed that, despite having more complex
anatomy at the time of the index procedure than men, women had
similar outcomes to men following treatment with the ultra-low
profile (14F) Ovation device:
- Freedom from AAA-related morality: 100%
in women vs 98.6% in men
- Freedom from reintervention for Type 1a
endoleak: 98.6% in women vs 97.9% in men
- Freedom from rupture: 100% in both
women and men
- Freedom from conversion: 100% in both
women and men
- Freedom from all device-related
reintervention: 97.2% in both women and men
Jennifer Ash, M.D., Christie Clinic Vein and Vascular Center and
Assistant Clinical Professor of Surgery, University of Illinois
College of Medicine in Champaign, said, “Women have specific
anatomical challenges in iliac access and proximal aortic neck
morphology and have historically had worse outcomes from EVAR than
men. The results of the LUCY study suggest that the unique features
of the low-profile Ovation system may overcome these challenges and
achieve similar outcomes in men and women.”4,5
John Onopchenko, Chief Executive Officer of Endologix, Inc.,
commented, “We are excited to have completed follow-up on the LUCY
study and are pleased that the one-year results suggest, for the
first time in a prospective study, that female AAA patients can be
treated with EVAR as effectively as men, when using the Ovation
System. LUCY’s evidence provides physicians with new information to
confidently engage female patients with prospectively derived
outcomes previously realized only by male patients.”
The LUCY study was led by an advisory board whose members
include: Chairperson Jennifer Ash, M.D., Christie Clinic Vein and
Vascular Center and Assistant Clinical Professor of Surgery,
University of Illinois College of Medicine in Champaign; Venita
Chandra, M.D., Clinical Assistant Professor of Surgery-Vascular
Surgery, Stanford School of Medicine; Monica Hunter, M.D.,
Birmingham Heart Clinic at St. Vincent’s Birmingham; Eva Rzucidlo,
M.D., McLeod Vascular and Associate Professor of Surgery, Geisel
School of Medicine, Dartmouth; and Ageliki Vouyouka, M.D.,
Associate Professor of Surgery and Radiology, Mount Sinai
Hospital.
1. Pinar Ulug, PhD, et al. www.thelancet.com Published
online April 25, 2017 Sweet, M, M.D., et al. J Vasc Surg 2011;
54:931-7. 2. Analysis based on available data from the LUCY Study
female cohort (72 out of 76) and on comparisons with grafts ranging
from 18F – 21F OD manufactured by global market leaders. Data
extracted on May 1, 2017. The Ovation Abdominal Stent Graft System
has not been studied in a head-to-head clinical study against other
EVAR devices for outcomes in women. 3. 2% of patients had vascular
characteristics beyond the FDA-approved anatomic IFU. Safety and
effectiveness, of Ovation when used off-IFU, have not been
established. 4. Mehta M, Byrne WJ, Robinson H, et al. “Women derive
less benefit from elective endovascular aneurysm repair than men.”
J Vasc Surg. Apr 2012;55(4):906-913. 5. Lowry, D, et al.
“Sex-related Outcome Inequalities in Endovascular Aneurysm Repair.”
Eur J Vasc Endovasc Surg (2016) 1-8.
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 Ovation System’s possible expansion of EVAR eligibility, and
other possible benefits of Endologix’s Ovation System, 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 Endologix’s Ovation System; risks
regarding the conduct of Endologix’s clinical trials, studies and
registries involving the Ovation System, including the results
thereof; risks regarding quality systems operations and outcome of
third party audits of such systems; risks regarding acceptance,
endorsement and use of Endologix's Ovation and other products;
risks associated with the manufacturing of Endologix’s Ovation and
other products; risks relating to Endologix’s product research and
development efforts; regulatory risks, including uncertainty in the
process of obtaining and maintaining U.S. FDA and other regulatory
approvals for the Ovation System; Endologix’s ability to access
equity and debt capital on acceptable terms; Endologix’s ability to
enter into or maintain existing financing arrangements on
acceptable terms; 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, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180628005260/en/
Investors:Endologix, Inc.Vaseem Mahboob,
949-595-7200CFO
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From Jul 2023 to Jul 2024