Endologix Reports Positive Preliminary Pivotal Trial Results Using the PowerLink System to Treat AAA.Business Editors & Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--Oct. 8, 2002 Endologix, Inc. (Nasdaq:ELGX) today announced favorable preliminary clinical results from a Phase II pivotal trial using the Company's PowerLink(TM) System, 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 ) for the treatment of abdominal aortic aneurysms (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. ). The results were presented by Dr. Jeffrey Carpenter, Professor of Surgery at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. , at the Transcatheter Cardiovascular Therapeutics (TCT TCT The Capital Times (Madison, WI newspaper) TCT Transcatheter Cardiovascular Therapeutics TCT The Coroner's Toolkit TCT Trans Canada Trail TCT Tcl Core Team TCT Tsukuba College of Technology (Japan) ) conference held September 23-28, 2002, in Washington, D.C. Based on the preliminary Phase II study results, Dr. Carpenter concluded that the PowerLink System appears safe, while providing protection from aortic aortic pertaining 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. ruptures with few complications and no material flaws. Of the patients treated as part of this multi-center Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) pivotal trial, Dr. Carpenter reported that the PowerLink System was successfully deployed in 115 patients without device-related, perioperative mortality. On average, patients were hospitalized less than three days and about one quarter were treated using local or epidural epidural /epi·du·ral/ (-dur´il) situated upon or outside the dura mater. ep·i·du·ral adj. Located on or over the dura mater. n. anesthetic forgoing the need for general anesthesia Anesthesia, General Definition General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs. . In follow-ups conducted between 10 and 25 months (with an average of 16 months) after the PowerLink System procedure, there were no indicated aneurysm aneurysm (ăn`y rĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart. ruptures, no wire fractures, and only one (0.8%) device migration, which required no additional therapy. Additionally, measurements taken one year after the procedure indicate a reduction in the mean aneurysm sac diameter for this cohort. The presentation also detailed a number of unique device design features that may be directly responsible for the favorable clinical results. Dr. Carpenter also reported on his extensive experience with five different ELGs at the University of Pennsylvania. The PowerLink has demonstrated the best results for Complication Free Survival, the ability to successfully implant a device, and continued survival without the need for additional surgical procedures during the follow-up period. Commenting on these clinical results, Dr. Carpenter called the PowerLink their "star performer." A demonstration of Endologix's ELG may be viewed on the Company's Web site, www.endologix.com. Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases vascular diseases, n.pl diseases of the peripheral circulatory system. . The Company's PowerLink(TM) System is an endoluminal stent graft (ELG) for treating 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 abdominal aortic aneurysms is approximately 75%, making it the 13th leading cause of death in the United States. Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, and which may be affected by, among other things, risks and uncertainties related to clinical trials and regulatory approval, to future economic, competitive and market conditions, including those in Europe and Asia and those related to Endologix's strategic markets, whether the products offered will achieve acceptance in the marketplace and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. In addition, the accuracy of the forward-looking statements in this news release are necessarily subject to other risks and uncertainties, and may be affected by, among other things, risks and uncertainties involving new product development and introduction cycles, research and development activities, including failure to demonstrate clinical efficacy, delays by regulatory authorities, scientific and technical advances by third parties, introduction of competitive products, third party reimbursement and physician training, and the risk factors and other matters set forth in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 2001, the Company's Quarterly Report on form 10-Q for the quarter ended June 30, 2002, the Company's proxy statement dated April 29, 2002 and the Company's Form 8-K filed June 13, 2002. |
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