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Data Presented at VEITH Symposium Support Durability of Endologix's Endoluminal Stent Graft.


Business Editors/Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Dec. 2, 2003

Endologix, Inc. (Nasdaq:ELGX) today announced that follow-up findings from a Phase II study of the Company's PowerLink(R) 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 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.
) lends evidence of the durability of the device's clinical results. Jeffrey Carpenter, M.D., 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.
, presented these findings at the VEITH symposium in New York.

In his remarks, Dr. Carpenter addressed positive preliminary findings from the Endologix PowerLink System pivotal trial, previously presented at the September 2003 Transcatheter Cardiovascular Therapeutics Conference. Of the 154 patients in the trial who have been monitored for a minimum of one year, 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 indicate a one-year endoleak rate of 5.8%, which compares favorably with currently marketed devices. Of the two (1.3%) incidences of late device migration, one was deemed clinically insignificant and did not require further treatment. No device-related aneurysm aneurysm (ăn`yrĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart.  ruptures, wire fractures or material failures associated with the PowerLink System were reported during this follow-up period.

The Company expects to file a full 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 with 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 during the second half of 2004.

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, "The VEITH symposium provides a prominent venue to showcase the positive attributes of our next-generation ELG to leading vascular surgeons from around the world. The preliminary U.S. pivotal trial data presented points to superior clinical results. The Company is completing its data collection and expects to submit its PMA application by the end of this year. The study cohort will consist of 259 patients, 193 test and 66 control patients. One-year data on more than 170 test patients as well as two-year follow up on approximately 60 test patients will be analyzed."

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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Publication:Business Wire
Geographic Code:1USA
Date:Dec 2, 2003
Words:506
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