Healthcare Industry News: abdominal aortic aneurysm
News Release - May 24, 2006
Endologix Receives FDA Approval for Visiflex Delivery SystemIRVINE, Calif.--(HSMN NewsFeed)--May 24, 2006--Endologix, Inc. (Nasdaq:ELGX ) today announced receipt of U.S. Food and Drug Administration (FDA) approval to begin marketing its next-generation Visiflex(TM) Delivery System for use with the PowerlinkŪ System for the minimally invasive treatment of abdominal aortic aneurysm (AAA). The Company obtained approval for this PMA supplement in 56 days. The Company plans to introduce the Visiflex Delivery System in the U.S. market through a controlled launch program to further develop targeted physician feedback and to build inventory, with full commercialization anticipated in the fall of this year.
The Visiflex Delivery System is designed to provide improved catheter flexibility for delivery of the Powerlink endoluminal stent graft (ELG) device. An integrated radiopaque band marker on the outer sheath and molded component parts are expected to enhance catheter visibility and facilitate smoother withdrawal in difficult anatomies. The Visiflex Delivery System has been CE Marked and used in Europe in Powerlink procedures, with very positive physician feedback to date.
"The new Visiflex Delivery System represents one of the measures we are taking to keep on the cutting edge of technology as we continue to expand commercial adoption of the Powerlink System," said Paul McCormick, president and chief executive officer of Endologix. "While our delivery catheter has been recognized as a key strength of the Powerlink System since initial market introduction, the Visiflex Delivery System offers the potential to substantially heighten this awareness among physicians with even greater ease of 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, , the accuracy of which are necessarily subject to risks and uncertainties, including risks related to changes in market acceptance of the Visiflex Delivery 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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