Endologix Announces Publication of Powerlink XL Clinical Trial Results
August 20 2009 - 9:00AM
PR Newswire (US)
IRVINE, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Endologix, Inc.
(NASDAQ: ELGX), developer of minimally invasive treatments for
aortic disorders, announced today the online publication of results
from the pivotal prospective, multicenter clinical trial of the
Company's Powerlink XL System for treatment of abdominal aortic
aneurysm in large diameter proximal aortic necks. This publication
follows the U.S. Food and Drug Administration (FDA) approval in
October 2008 of the device and treatment algorithm as a safe and
effective endovascular option in patients with infrarenal aortic
necks up to 32 millimeters in diameter. The trial showed aneurysm
exclusion in 100% of patients at the pivotal one-year follow-up
timepoint, with no conversions to open surgical repair, no ruptures
and no device migrations. In addition, core lab evaluations of
one-year follow up results show 96% of patients had reduced or
stable aneurysm sac diameters and there were no aneurysm related
mortalities, no stent fractures or limb occlusions, and no Type III
or Type IV endoleaks. William D. Jordan Jr., MD, Chief of Vascular
Surgery at University of Alabama at Birmingham, and study
investigator in the Powerlink XL trial, said, "There is mounting
clinical evidence demonstrating the significant benefits of
anatomical fixation in the treatment of AAA, including the results
from this study, which shows Powerlink XL's ability to effectively
treat patients with large aortic necks. These results are
particularly remarkable considering that 85% of the patients in the
trial had challenging infrarenal aortic neck anatomies, such as
severe thrombus and/or reverse taper, which are considered to be
among the most difficult to treat during endovascular repair." The
study, which is titled "Secure fixation following EVAR with the
Powerlink XL System in wide aortic necks: Results of a prospective,
multicenter trial," was published online on the Web site of the
Journal of Vascular Surgery (JVS) and will published in an upcoming
issue of JVS. The study was authored by William D. Jordan Jr., MD,
William M. Moore, Jr., MD, Jim G. Melton, DO, O. William Brown, MD,
JD, and Jeffrey P. Carpenter, MD. The 78-patient study was
conducted at 13 centers across the United States according to FDA
regulations and guidelines. The trial was designed to study the
safety and effectiveness of the Endologix Powerlink XL device in
the treatment of patients with large aortic necks up to 32
millimeters in diameter. This is the first FDA study to evaluate
the effectiveness of the placement of the Powerlink single-piece
bifurcated device on the native aortic bifurcation (anatomical
fixation) together with the Powerlink XL proximal extension. John
McDermott, Endologix President and Chief Executive Officer, said,
"We are very pleased to announce the publication of exceptional
results from our Powerlink XL clinical trial, expanding the
clinical evidence supporting the broad use of our products in
patients with AAA. We believe these clinical outcomes utilizing
Powerlink XL in difficult to treat patients will help increase our
share of the large neck AAA market and also contribute to the
transition of patients from open surgical to endovascular AAA
repair." Mr. McDermott concluded, "The successful outcomes achieved
in the trial mirror what we have been seeing in the field as we
leverage successful outcomes with Powerlink XL to introduce
surgeons to our products and gain more of their everyday business.
Adoption of Powerlink XL is also benefitting from the recent launch
of the IntuiTrak Express Delivery System, which simplifies the
procedure and is the lowest profile delivery system in the United
States to treat AAA patients with aortic necks greater than 28
millimeters." About Journal of Vascular Surgery Journal of Vascular
Surgery provides vascular, cardiothoracic, and general surgeons
with the most recent information in vascular surgery. Original,
peer-reviewed articles cover clinical and experimental studies,
noninvasive diagnostic techniques, processes and vascular
substitutes, microvascular surgical techniques, angiography, and
endovascular management. Special issues publish papers presented at
the annual meeting of the Journal's sponsoring society, the Society
for Vascular Surgery. Journal of Vascular Surgery ranks in the top
5% of the 5,684 scientific journals most frequently cited (2000
Science Citation Index). 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.
Additional information can be found on Endologix's Web site at
http://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 XL Infrarenal
Proximal Extension 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, 2008, 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 http://www.endologix.com/
DATASOURCE: Endologix, Inc. CONTACT: John McDermott, CEO,
Endologix, Inc., +1-949-595-7200; or Nick Laudico, +1-646-536-7030,
or Zack Kubow, +1-646-536-7020, both of The Ruth Group Web Site:
http://www.endologix.com/
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