Endologix, a developer of minimally invasive treatments for aortic disorders, has received FDA approval for its expanded offering of Powerlink stent graft products. The 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%.
Endologix said that the new products are expected to be launched in a limited market release at the 2010 Annual Meeting of the Society for Vascular Surgery, at the Hynes Convention Center in Boston, MA. The company expects to launch the new product line extensions in a full market release during the fourth quarter of 2010.
John McDermott, president and chief executive officer said: “The approval of our expanded Powerlink product line offering is a significant achievement for Endologix as we continue to drive market adoption of our innovative anatomical fixation technology. The broadened family of devices will allow physicians to use our products to treat a wider group of patients with abdominal aortic aneurysm, including those with short common iliac arteries.
“In addition, the breadth of new bifurcated devices and proximal extensions will enable physicians to tailor the endovascular repair to each patient’s unique anatomical requirements. All of these new sizes are designed for seamless integration with our existing products and will be delivered with the IntuiTrak Endovascular System.”