Endologix, 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 US Food and Drug Administration (FDA) approval for these new products and they are currently in a limited market release in the US, with a full release planned for the fourth quarter of 2010.
Company president and CEO John McDermott 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 US 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 US and Europe as physicians are able to utilise 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 millimetres in diameter. In addition, the PowerFit product line is available with longer stent lengths of up to 120 millimetres, to expand the treatment options for physicians and their patients.