IRVINE, Calif., April 28 /PRNewswire-FirstCall/ -- Endologix,
Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for
aortic disorders, announced today the publication of consolidated
results from its prospective, multicenter clinical trials of the
Company's Powerlink® stent graft for the endovascular repair of
abdominal aortic aneurysms (AAA) using an anatomical fixation
technique. The trial results demonstrate no aneurysm ruptures, no
conversions to open repair, no device migrations, no stent
fractures, no graft fatigue, no junctional endoleaks, no transgraft
endoleaks, and 100% freedom from aneurysm-related mortality for up
to five years post-implant. In addition, core lab evaluations found
a low rate of limb occlusion (0.6% of limbs), with significantly
reduced or stable aneurysm sacs in 95% and 93% of patients at one
year and five years, respectively.
Lead author of the publication, Jeffrey
P. Carpenter, M.D., Professor and Chief, Department of
Surgery, UMDNJ-Robert Wood Johnson Medical School, Camden, stated,
"The current and consolidated results of the anatomical fixation
technique using the Powerlink system for the treatment of AAA
provides further compelling evidence to clinically validate this
treatment modality. The long-term results of the study, which
include no device failures and significant reductions in aneurysm
sac volume, compare favorably with existing clinical data using
proximal fixation devices. The results are particularly positive
considering that 83% of trial patients had hostile aortic neck
anatomies, which can increase the risk that the procedure will
fail. Moreover, given the known prevalence of peripheral arterial
disease in AAA patients, preservation of the aortic bifurcation for
future peripheral interventions is a clinically significant benefit
of anatomical fixation compared with proximal fixation."
The study, which is titled "Contemporary Results of Endovascular
Repair of Abdominal Aortic Aneurysms: Effect of Anatomical Fixation
on Outcomes" was published in the April
2010 edition of the Journal of Endovascular Therapy
(www.jevt.org). The study was co-authored by a group of
multidisciplinary investigators from the Company's Powerlink
clinical trials, including Jeffrey P.
Carpenter, MD; Mark J.
Garcia, MD; Stuart A. Harlin,
MD; William D. Jordan, Jr., MD;
Matthew T. Jung, MD; Zvonimir Krajcer, MD; and Julio A. Rodriguez-Lopez, MD. The study presents
consolidated results from two previously published Powerlink
studies and one additional Powerlink study that has been submitted
for publication.
The study reports the initial, mid-term, and available long-term
results for 157 patients treated with the Powerlink system at 28
centers across the United States
according to FDA regulations and approved protocols. All patients
received the Powerlink infrarenal bifurcated stent graft via the
anatomical fixation technique, with concomitant proximal sealing
achieved with a Powerlink aortic extension as dictated by patient
anatomical needs.
Anatomical fixation with Endologix's Powerlink system was
developed by the Company in conjunction with early physician users.
The technique leverages the unique unibody design of the
Powerlink device and the foundational support of the patient's own
aortoiliac bifurcation to naturally inhibit device migration, which
is a recognized failure mode of endovascular devices, including
proximal fixation stent graft systems that are traditionally placed
at the renal arteries. In addition, Powerlink's unibody
design and fixation via anatomical fixation at the patient's
aortoiliac bifurcation closely mimics the patient's original
anatomy. This makes it possible for Powerlink patients to
undergo future procedures for peripheral arterial disease, which
requires arterial access from the opposite femoral artery, crossing
through the stent graft. This type of access is not
recommended, and in many patients is not possible, after AAA repair
using a proximal fixation device.
John McDermott, President and
Chief Executive Officer said, "We applaud the publication authors
and all of the trial physicians on their achievement. It is a high
priority for the Company to continue to collaborate with the
medical community to provide evidence-based clinical data to
practitioners treating AAA to help them achieve the best possible
outcomes for their patients. These results continue to reinforce
the patient-centered benefits of Powerlink stent graft implantation
using an anatomical fixation technique, particularly for patients
with hostile aortic neck anatomies. We believe these comprehensive
outcomes will support increased adoption of endovascular repair in
general, and more specifically, of the Powerlink System."
About The Journal of Endovascular Therapy
Journal of Endovascular Therapy, an official publication of the
International Society of Endovascular Specialists, publishes
peer-reviewed articles of interest to clinicians and researchers in
the field of endovascular interventions. The Journal's scope is
multidisciplinary, representing all topics related to minimally
invasive peripheral vascular diagnosis and treatment. Original
clinical studies, experimental investigations, state-of-the-art
reviews, rapid communications, case reports, technical notes,
editorials and letters to the editor are published, as well as
feature articles on the basics of endovascular interventions.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive
treatments for aortic disorders. The Company's flagship product is
the Powerlink® System, which is an endovascular stent graft 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 75%, making it a leading cause of death in the U.S.
Additional information can be found on Endologix's Web site at
www.endologix.com.
Forward-Looking Statements
Except for historical information contained herein, this news
release contains forward-looking statements, specifically including
expected physician acceptance of the Endologix Powerlink System,
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 from
anticipated results, including the success of sales efforts for the
Powerlink System and related new products, product research and
development efforts, and other economic, business, competitive and
regulatory factors. The Company undertakes no obligation to update
its forward looking statements. Please refer to the Company's
Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other
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:
|
INVESTOR
CONTACTS:
|
|
Endologix, Inc.
|
The Ruth
Group
|
|
John McDermott, CEO
|
Nick Laudico (646)
536-7030
|
|
(949) 595-7200
|
Zack Kubow (646) 536-7020
|
|
www.endologix.com
|
|
|
|
|
SOURCE Endologix, Inc.