Healthcare Industry News: abdominal aortic aneurysm
News Release - April 25, 2006
Endologix Receives FDA Approval for the Powerlink-120 ELGIRVINE, Calif.--(HSMN NewsFeed)--April 25, 2006--Endologix, Inc. (Nasdaq:ELGX ) today announced receipt of the U.S. Food and Drug Administration's (FDA) approval to market new short body/short limb variants of the PowerlinkŪ System endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA). The company expects that the two Powerlink-120 models will address 5-10% of AAA patients currently excluded from treatment due to anatomical considerations. Endologix plans to begin marketing the new devices in May of this year.
"Our team worked quickly to gain marketing approval under the interactive PMA supplement 'real-time' review program. The FDA approved these two new Powerlink-120 models within 50 days," said Paul McCormick, president and chief executive officer of Endologix. "We envision our Powerlink System as a platform, and our new short body/short limb ELG configurations are among several product enhancements and line extensions that we plan to introduce in an effort to expand the Powerlink System's commercial use."
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.
Except for historical information contained herein, this news release contains forward-looking statements, including those relating to commencing marketing of the new Powerlink-120 models and new product enhancements and line extension of the Powerlink System, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to changes in market acceptance of the Powerlink System, 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's Annual Report on Form 10-K for the year ended December 31, 2005, and Endologix's other filings with the Securities and Exchange Commission.
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