Healthcare Industry News: abdominal aortic aneurysm
News Release - December 31, 2012
Endologix IntuiTrak Delivery System Receives Shonin Approval for Marketing in JapanIRVINE, Calif., Dec. 31, 2012 -- (Healthcare Sales & Marketing Network) -- Endologix, Inc. (ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that its distribution partner in Japan, Cosmotec Inc., has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the IntuiTrak(R) Delivery System. The IntuiTrak System delivers the Company's Powerlink(R) anatomical fixation stent graft for the minimally invasive endovascular repair of abdominal aortic aneurysms (AAA).
IntuiTrak builds upon the strong clinical results achieved with the Powerlink stent graft in multicenter, prospective clinical trials. It adds ergonomic features, a simplified deployment mechanism and hydrophilic coating to ease access and delivery, compared to the previous system available for the device in Japan. Endologix stent-grafts have now been used to successfully repair more than thirty thousand AAA's worldwide with very positive physician acceptance.
Bob Mitchell, President, International of Endologix, said, "We are very pleased to announce the approval of IntuiTrak in Japan, which has been a very good market for our anatomical fixation technology. When we introduced IntuiTrak in the U.S. and other markets, we received very positive feedback on its ease of access and the simplification of the delivery and deployment mechanism. We anticipate a similar response to IntuiTrak in Japan and look forward to working closely with Cosmotec over the next few months to train their sales reps and physician proctors, with the expectation of commencing the first IntuiTrak commercial cases in Q2 2013."
About Endologix, Inc.
Endologix, Inc. (the "Company") develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of 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 relating to the introduction and market acceptance of the IntuiTrak System in Japan, 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. Many factors may cause actual results to differ materially from anticipated results, including delays in training and marketing activities and other economic, business, competitive and regulatory factors. 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, 2011, 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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