IRVINE, Calif., June 10 /PRNewswire-FirstCall/ -- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (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%. The new products will be launched in a limited market release at the 2010 Annual Meeting of the Society for Vascular Surgery, June 10-13, 2010, 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. We look forward to introducing our expanded Powerlink® product line to the medical community at the SVS Annual Meeting and further drive broader adoption in the fourth quarter of this year.”
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company’s flagship product is the Powerlink® System, which is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix’s Web site at www.endologix.com.
Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including the success of sales efforts for the Powerlink System and related new products, product research and development efforts, and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, and the Company’s other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
COMPANY CONTACT: | INVESTOR CONTACTS: | |
Endologix, Inc. | The Ruth Group | |
John McDermott, CEO | Nick Laudico (646) 536-7030 | |
(949) 595-7200 | Zack Kubow (646) 536-7020 | |
SOURCE Endologix, Inc.