Six-Year Follow-up Data Confirms Endologix Powerlink's Outstanding Durability and Outcomes
September 03 2008 - 4:00AM
Business Wire
Endologix, Inc. (Nasdaq:ELGX) today announced that six-year patient
follow-up data from the Company�s Powerlink� System pivotal
clinical trial supporting the durability of the Powerlink System as
a minimally invasive treatment for abdominal aortic aneurysm (AAA)
was published in the peer-reviewed Journal of Vascular Surgery
(September 2008). A link to the abstract �The Powerlink System for
endovascular abdominal aortic aneurysm repair: Six-year results� is
available at www.endologix.com. Highlights from the six-year
follow-up of patients treated with the Powerlink System include:
97.9% freedom from AAA mortality Excellent device performance and
integrity, with no ePTFE graft failures, no stent fractures, no
aneurysm ruptures Remarkably low incidence of secondary procedures
to treat Type I endoleak (3.1%) or a limb occlusion (1.6%) No
migration in patients who received the device via an anatomical
fixation technique Significant aneurysm sac diameter reduction in
83% of patients Endologix investigator and article co-author
Jeffrey P. Carpenter, M.D., of the Hospital of the University of
Pennsylvania, stated, �The safety and effectiveness of the
Powerlink device at early and intermediate time points have
previously been reported and we now have long-term data indicating
the Powerlink System is just as durable in protecting patients from
aneurysm-related death as open repair. The Powerlink-treated cohort
demonstrated significant aortic aneurysm sac shrinkage and
straightening, which proved instrumental in avoiding late
complications and reinterventions. Further, the Powerlink device�s
unibody design allows for delivery through a low-profile catheter
and single incision site, which facilitates placement in patients
with limited and difficult access.� Endologix President and CEO
John McDermott said, �We are pleased with the continued clinical
performance of the Powerlink System and the growing body of
evidence that demonstrates long-term durability and positive
outcomes. In the months ahead, we will be introducing new devices
and supporting clinical data that further expand the number of
patients that can be treated with the Powerlink System.� About
Endologix Endologix, Inc. develops and manufactures minimally
invasive treatments for vascular diseases. Endologix's Powerlink
System is an endoluminal stent graft for treating 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. Except for historical information contained
herein, this news release contains forward-looking statements
relating to the introduction of new products and continuing
clinical results obtained with the 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. 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, 2007, 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.
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