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August 25, 2010
Endologix Receives CE Mark Approval for Expanded Line of Powerlink and PowerFit Devices
August 26, 2010—Endologix, Inc. (Irvine, CA) announced that it has received CE Mark approval to market its expanded line of Powerlink stent graft products and PowerFit aortic extensions in the European Union. The company expects to conduct a limited market release in Europe during the fourth quarter of 2010 followed by a full product launch in 2011. Endologix recently received US Food and Drug Administration approval for these new products, and they are currently in a limited market release in the United States, with a full market release planned for the fourth quarter of 2010.
According to the company, the CE Mark approval covers 31 new sizes of Powerlink main body bifurcated, proximal extension, and limb extension stent grafts. It also covers PowerFit aortic extensions, which are available in a range of sizes indicated for treating aortic necks ranging from 18 to 32 mm in diameter. In addition, the PowerFit product line is available with longer stent lengths of up to 120 mm.
The company stated that the new sizes of Powerlink stent grafts will allow physicians to treat a wider group of patients, including those with short iliac arteries, and the PowerFit aortic extensions feature improved visibility, conformability, and sealing.
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