Endologix Completes Patient Enrollment in the Ovation® LUCY Study
February 14 2017 - 4:01PM
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative
treatments for aortic disorders, announced today that it has
completed patient enrollment in the LUCY (Evaluation of
Fema
Les who are
Underrepresented
Candidates for Abdominal Aortic
Aneur
Ysm Repair) study, a multi-center post-market
registry designed to explore the clinical benefits associated with
endovascular aneurysm repair (EVAR) using the Ovation® Abdominal
Stent Graft Platform in female patients with abdominal aortic
aneurysms ("AAA"), as compared to males. It is the first
prospective study evaluating EVAR in females, a population that has
historically been underrepresented in EVAR clinical trials.
The LUCY study enrolled a total of 225 patients, including 75
females in the treatment group and 150 males in the control group,
at 39 sites in the United States. The primary endpoint of the study
is the 30-day Major Adverse Event ("MAE") rate. The 30-day results
from the LUCY study are anticipated to be presented at a medical
meeting in the summer of 2017. The LUCY Study is led by an advisory
board whose members include: Chairperson, Jennifer Ash, MD,
Christie Clinic Vein and Vascular Center and Assistant Clinical
Professor of Surgery University of Illinois College of Medicine, in
Urbana-Champaign; and Members Venita Chandra, MD, Clinical
Assistant Professor Surgery-Vascular Surgery, Stanford School of
Medicine; Monica Hunter, MD, Birmingham Heart Clinic at St.
Vincent’s, Birmingham; Eva Rzucidlo, MD, McLeod Vascular and
Associate Professor of Surgery Geisel School of Medicine,
Dartmouth; and Ageliki Vouyouka, MD, Associate Professor Surgery
and Radiology, Mount Sinai Hospital.
Dr. Chandra commented, “Women have historically been
underrepresented in EVAR clinical trials. One factor precluding
women has been that traditional EVAR devices have been unable to
accommodate the anatomic variances found in women, such as smaller
access vessels and more challenging proximal aortic necks, compared
to their male counterparts. The LUCY study is the first prospective
study evaluating EVAR in a female population and it will make an
important contribution to understanding the management and outcomes
of women and other patients with similar anatomy.”
Dr. Ash added, “Retrospective analyses of women treated with
traditional EVAR devices have consistently shown that women tend to
have greater morbidity and mortality from EVAR intervention. Our
preliminary analysis of the patients who have completed their
30-day follow-up visits suggest that women in the LUCY Study
derived similarly favorable benefits from the Ovation Platform’s
ultra-low profile delivery system and unique proximal sealing ring
as compared to their male counterparts. We look forward to
completing the patient follow-up and presenting the analysis at an
upcoming meeting.”
John McDermott, Chief Executive Officer of Endologix, said, “The
completion of enrollment in the LUCY study is another important
milestone in our efforts to continue building the clinical evidence
in support of our innovative portfolio of AAA products. It
highlights our commitment to developing technologies that can
improve clinical outcomes for AAA patients, including populations
such as women that have historically been underserved with existing
technologies. I would like to thank the clinical investigators and
trial sites for their participation and support of this important
clinical study.”
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. Additional information can be found on Endologix's website
at www.endologix.com.
Forward-Looking StatementsThis communication
includes statements that may be "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including with respect to the continued collection of
clinical data and the anticipated results therein, the accuracy of
which are necessarily subject to risks and uncertainties, all of
which are difficult or impossible to predict accurately and many of
which are beyond the control of Endologix. Many factors may cause
actual results to differ materially, including difficulties in
patient follow-up and unanticipated clinical outcomes. Undue
reliance should not be placed on forward-looking statements, which
speak only as of the date they are made. Endologix undertakes no
obligation to update any forward-looking statements 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 Annual Report on Form 10-K for the year ended
December 31, 2015, and Endologix's subsequent filings with the
Securities and Exchange Commission, for more detailed information
regarding these risks and other factors that may cause actual
results to differ materially from those expressed or implied.
COMPANY CONTACT:
Endologix, Inc.
John McDermott, CEO
Vaseem Mahboob, CFO
(949) 595-7200
www.endologix.com
COMPANY CONTACT:
Endologix, Inc.
John McDermott, CEO
Vaseem Mahboob, CFO
(949) 595-7200
www.endologix.com
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