Four-Year Patient Follow-up Data Support Safety and Effectiveness of Endologix's Powerlink System; Three Presentations Highlight Powerlink at the International Congress XIX on Endovascular Interventions.IRVINE, Calif. -- 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 ELG Early Learning Goals (education) ELG Export-Led Growth ELG Endoluminal Graft ELG Effluent Limitation Guideline ELG European Liaison Group ELG Executive Level Group ELG Engineering Log Generator ) in protecting patients from rupture of the abdominal aortic aneurysm abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105 (AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. ). Rodney A. White, M.D., Professor of Surgery at UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX School of Medicine and Chief of Vascular Surgery at Harbor-UCLA Medical Center Harbor-UCLA Medical Center is a hospital located within the city of Torrance, California, USA. The hospital was founded in 1946, and is funded by Los Angeles County Harbor-UCLA serves as the Level I Trauma Center for the South Bay area. , 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 EVAR Endovascular Aneurysm Repair EVAR Experimental Vehicle for Avionics Research EVAR Extravehicular Activity Retriever ," 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 aneurysm (ăn`y rĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart. 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 aorticpertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. bifurcation Bifurcation A term used in finance that refers to a splitting of something into two separate pieces. Notes: Generally, this term is used to refer to the splitting of a security into two separate pieces for the purpose of complex taxation advantages. . 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 pre·op·er·a·tive adj. Preceding a surgical operation. preoperative preceding an operation. preoperative care the preparation of a patient before operation. 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 angulation /an·gu·la·tion/ (ang?gu-la´shun) 1. formation of a sharp obstructive bend, as in the intestine, ureter, or similar tubes. 2. deviation from a straight line, as in a badly set bone. over three years than patients with smaller aneurysms. A third topic, "Endovascular Aneurysm Repair (EVAR) With Suprarenal suprarenal /su·pra·re·nal/ (-re´nal) 1. above a kidney. 2. adrenal. su·pra·re·nal adj. Located on or above the kidney. n. 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 The University of Pennsylvania's School of Medicine, presently located in the University City section of Philadelphia, Pennsylvania, was the United States's first school of medicine, founded at the College of Philadelphia, as the University was then called. , 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. |
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