Healthcare Industry News: abdominal aortic aneurysm
News Release - February 11, 2008
Endologix Launches the Powerlink System in JapanIRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq: ELGX ), the developer and manufacturer of the Powerlink® System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), today announced that it has received notice of Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) and will soon be initiating Powerlink System product shipments to Japan.
“We are delighted with this approval, which marks the successful culmination of our efforts with the Japanese regulatory agency,” said Paul McCormick, president and chief executive officer of Endologix. “We will begin by shipping an initial stocking order this month to our Japanese distributor COSMOTEC Co. Ltd. and expect that the first Powerlink System implants will be performed at the Tokyo Medical University Hospital. These trained physicians will serve as proctors to further train additional physicians with the minimally invasive Powerlink System procedure. Uptake is anticipated to increase over time as more physicians in Japan gain experience with the Powerlink System.
“We envision a long-term market opportunity for the Powerlink System in Japan. We estimate that approximately 14,000 open repair surgeries are performed annually in this country and the timing of our approval coincides well with the reimbursement for endoluminal stent graft procedures established last year,” he added.
Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix’s Powerlink System is an endoluminal stent graft 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 a 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 our belief that endovascular repair will achieve clinical acceptance in Japan and that the Powerlink System will be adopted by vascular surgeons in the Japanese market, 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. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, and the Company’s other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
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