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Endologix, Inc.
, 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^® Delivery System. The IntuiTrak
System delivers the Company's Powerlink^® 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."
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