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 32mm in diameter.
In addition, the PowerFit product line is available with longer stent lengths of up to 120mm, to expand the treatment options for physicians and their patients.
Endologix has recently received US Food and Drug Administration approval for the new products and they are currently in a limited market release in the US, with a full market release in the US planned for the fourth quarter of 2010.
Endologix president and chief executive officer John McDermott said that they have received extremely positive feedback from US physicians on the new sizes and PowerFit, which gives us confidence that the 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,” McDermott said.
Endologix 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.
