ELGX Endologix Inc

Endologix, Inc. (Nasdaq:ELGX) today announced that four-year patient follow-up data from the Company's Powerlink(R) System pivotal clinical trial supports the safety and effectiveness of the Powerlink as an endoluminal stent graft (ELG) in protecting patients from rupture of the abdominal aortic aneurysm (AAA). Rodney A. White, M.D., Professor of Surgery at UCLA School of Medicine and Chief of Vascular Surgery at Harbor-UCLA Medical Center, presented the data at the International Congress XIX on Endovascular Interventions. Two additional presentations featuring AAA treatment with the Powerlink System were also presented at this meeting. Dr. White's presentation, "Four-year Results of the Pivotal U.S. Multicenter Trial for the Endologix Powerlink Endograft for EVAR," presented follow-up from 192 patients treated with the Powerlink System in Endologix's pivotal clinical trial. The mean follow-up patient time was 36.1 months with a range of .03 - 62.0 months. Dr. White reported that only 26 patients from the follow-up group required a secondary procedure and most were treated for Type II endoleak, indicating that the need for the secondary procedure was not device related. Dr. White further noted that all cohorts treated with the Powerlink System experienced aneurysm sac diameter and volume reductions, shrinking of the aneurysm sac around the device, and minimal change in the length of the aorta from the most distal renal artery to aortic bifurcation. The Powerlink's column strength and unique long main body may directly influence the remodeling of the aneurismal aorta. Of the 192 patients followed for 48 months: -- 97.9% of patients were free from AAA-related mortality -- There were no reported aneurysm ruptures -- There were no ePTFE graft material failures -- There were no cobalt chromium stent graft failure or fatigue -- There was only one late conversion that occurred at one year The second presentation, "Does Preoperative AAA Size Influence Sac Regression and Classical Remodeling the Powerlink System?" by James Williams, M.D., and Michael Brown, M.D., concluded: -- Treatment of AAA (less than or equal to 50mm) provided nearly complete sac regression to near normal aortic measurement within the first three years post treatment. -- Patients with aneurysms (greater than 50mm) experienced a larger percentage reduction in mean sac diameter and greater straightening of sac angulation over three years than patients with smaller aneurysms. A third topic, "Endovascular Aneurysm Repair (EVAR) With Suprarenal Versus Infrarenal Fixation: A Controlled Study of Renal Effects," submitted by Shane Parmer, M.D., and Jeffrey P. Carpenter, M.D., both from the University of Pennsylvania School of Medicine, was presented. In an analysis in which 79 patients received suprarenal fixation and 47 received infrarenal fixation, the authors concluded: -- Suprarenal fixation does not result in a significant increase in acute renal events, renal impairment or alterations in blood pressure control in comparison to infrarenal fixation. "The International Congress provides an excellent forum to highlight the positive attributes of our Powerlink System, supporting our objective of driving physician acceptance for our ELG," said Paul McCormick, Endologix president and chief executive officer. "These presentations reinforced earlier findings about the long-term durability of our Powerlink ELG and this procedure's benefit in treating aortic aneurysm disease." 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.