ELGX Endologix Inc

Endologix, Inc. (Nasdaq:ELGX) today announced that the Company's new, larger manufacturing facility has been approved by both the State of California Food and Drug Branch and the U.S. Food and Drug Administration (FDA) for the production of its Powerlink(R) System for the minimally invasive treatment of patients with abdominal aortic aneurysm (AAA). The Company has also completed the voluntary limited product recall announced in December 2005. This action did not involve any Powerlink devices already implanted in patients and the Company reported no interruption in Powerlink System product availability due to this action. "We worked interactively with the FDA and we appreciate its timely review and approval of our new facility, which was granted without any Form FDA-483 observations. We believe we now have ample manufacturing capacity to handle increased sales of our Powerlink System as we continue our U.S. product launch," said Paul McCormick, president and CEO of Endologix. "Further, our manufacturing, quality, engineering and regulatory teams promptly identified and implemented manufacturing improvements to the Powerlink delivery catheter tip and interacted with FDA field investigators and the Agency to review the corrective actions. We believe we acted responsibly and, needless to say, are pleased with the cooperative efforts made by the FDA." About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft (ELG) for treating 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 the thirteenth leading cause of death in the U.S. In October 2004, Endologix received approval to market the Powerlink in the U.S. Additional information can be found on Endologix's Web site at www.endologix.com. Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to changes in regulatory requirements, and product liability claims, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2004, and the Company's other filings with the Securities and Exchange Commission.