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Endologix Provides Japanese Approval Update for Powerlink System.


IRVINE, Calif. -- Endologix, Inc. (Nasdaq:ELGX) today announced progress with the process to obtain Shonin approval to market the Powerlink[R] System in Japan. The Pharmaceutical and Medical Devices Agency (PMDA PMDA Plastics Machinery Distributors' Association (United Kingdom)
PMDA Plutonium Management and Disposition Agreement (US-Russia)
PMDA Pharmaceuticals and Medical Device Agency (Japan) 
) of the Japanese Ministry of Health, Labour and Welfare recently conducted its Expert Panel Meeting. As part of that meeting, the PMDA made requests that Endologix intends to fulfill with readily available information.

"Our plan is to work over the next several weeks with our Japanese distributor Cosmotec Co. Ltd. to provide responses to the PMDA in order for them to conclude their review of our Shonin application," stated Paul McCormick, president and chief executive officer of Endologix. "We are encouraged with this productive dialogue involving the Japanese regulatory authorities, and with progress that is consistent with our plans and preparations to bring our minimally invasive 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  disease to this key market," he added.

About Endologix

Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases vascular diseases,
n.pl diseases of the peripheral circulatory system.
. Endologix's Powerlink System is an endoluminal stent graft Difference Between a Stent Graft and a Stent
A stent graft is a tubular device, which is composed of special fabric supported by a rigid structure, usually metal. The rigid structure is called a stent.
 (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 treating 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.
). 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. Additional information can be found on Endologix's Web site at www.endologix.com.

This press release contains forward-looking statements with respect to the regulatory process for approval of the Powerlink System, the accuracy of which are necessarily subject to risks and uncertainties, 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 Endologix 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 December 31, 2005, and Endologix's other filings with the Securities and Exchange Commission. Endologix undertakes no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 21, 2006
Words:365
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