Favorable Preliminary Findings from Endologix PowerLink Pivotal Clinical Trial Presented at TCT Conference.Business Editors/Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--Sept. 18, 2003 Endologix, Inc. (Nasdaq:ELGX) today reported that positive findings from the first 154 patients enrolled in the pivotal trial for the Company's PowerLink(R) 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. ), were presented 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 in Washington, D.C. The preliminary pivotal trial findings 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. . Data was presented on 154 patients who were monitored for a minimum of one year, 37 of which were followed for up to two years. The PowerLink was safely deployed in 151 patients (98%) with no device related deaths during the perioperative perioperative /peri·op·er·a·tive/ (-op´er-ah-tiv) pertaining to the period extending from the time of hospitalization for surgery to the time of discharge. per·i·op·er·a·tive adj. period. The findings further indicated a one-year endoleak rate of 5.8%, which compares favorably to currently marketed devices. Of the two late device migration (1.3%) incidences, one was deemed clinically insignificant and did not require further treatment. No aneurysm ruptures, wire fractures or material failures associated with the PowerLink System were reported during the follow-up period. During his presentation, Dr. Carpenter commented, "The results of the study show the PowerLink System's unique single-piece bifurcated bi·fur·cate v. bi·fur·cat·ed, bi·fur·cat·ing, bi·fur·cates v.tr. To divide into two parts or branches. v.intr. To separate into two parts or branches; fork. adj. design and delivery system can be deployed quickly with a high degree of success and minimal complications. I have been duly impressed with the low endoleak rate as well as with the durability of the stent." Endologix President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Paul McCormick said, "Presenting these favorable clinical findings at the prestigious TCT conference should support our efforts to gain physician acceptance for the PowerLink. Our ELG devices appear to be effective and safe based on more than 1,400 implants worldwide, and the preliminary U.S. clinical trial data provides additional supportive evidence in gaining acceptance of the PowerLink technology." The Company expects to submit the final module in its pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) submission for the PowerLink System to the U.S. Food and 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. ) later this year, and anticipates receiving U.S. marketing approval in second half of 2004. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. AAA, a life threatening condition, 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 AAAs 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, including risks related to clinical trials and the regulatory approval process, 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 Dec. 31, 2002 and the Company's other filings with the U.S. Securities Exchange Commission. |
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