IRVINE, Calif., Aug. 26 /PRNewswire-FirstCall/ -- Endologix, Inc.
(Nasdaq: ELGX), developer of minimally invasive treatments for
aortic disorders, announced today that it received CE Mark approval
to market its expanded offering of Powerlink® stent graft products
and PowerFit™ Aortic Extensions in the European Union. The
Company expects to launch the products in a limited market release
in Europe during the fourth
quarter of 2010, followed by a full product launch in 2011.
Endologix recently received U.S. Food and Drug Administration
(FDA) approval for these new products and they are currently in a
limited market release in the U.S., with a full market release in
the U.S. planned for the fourth quarter of 2010.
John McDermott, President and
Chief Executive Officer of Endologix, said, "We are excited to
begin rolling out our expanded product portfolio following its
limited market release in the United
States during the third quarter. We have received
extremely positive feedback from U.S. physicians on the new sizes
and PowerFit, which gives us confidence that these new devices will
be well received in the European market. The new sizes of
Powerlink stent grafts are allowing physicians to treat a wider
group of patients, including those with short iliac arteries.
Physicians are also benefitting from the improved visibility,
conformability and sealing achieved with the PowerFit Aortic
Extensions. All together, we now have a comprehensive AAA
product offering that will allow us to gain additional market share
in the U.S. and Europe as
physicians are able to utilize anatomical fixation for more of
their AAA patients."
The CE Mark approval covers 31 new sizes of Powerlink main body
bifurcated, proximal extension, and limb extension stent grafts
that increase the system's addressable patient population by 5% to
10%. It also covers PowerFit Aortic Extensions, which are available
in a range of sizes indicated to treat aortic necks ranging from 18
to 32 millimeters in diameter. In addition, the PowerFit product
line is available with longer stent lengths of up to 120
millimeters, to expand the treatment options for physicians and
their patients.
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, 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:
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INVESTOR
CONTACTS:
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Endologix, Inc.
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The Ruth Group
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John McDermott, CEO
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Nick Laudico (646)
536-7030
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(949) 595-7200
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Zack Kubow (646)
536-7020
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www.endologix.com
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SOURCE Endologix, Inc.
Copyright . 26 PR Newswire