Healthcare Industry News: abdominal aortic aneurysm
News Release - December 21, 2006
Endologix Provides Japanese Approval Update for Powerlink SystemIRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq:ELGX ) today announced progress with the process to obtain Shonin approval to market the PowerlinkŪ System in Japan. The Pharmaceutical and Medical Devices Agency (PMDA) 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 disease to this key market," he added.
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. 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 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.
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