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 indica
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