Market Overview

Endologix IntuiTrak Delivery System Receives Shonin Approval for Marketing in Japan


Endologix, Inc. (Nasdaq: 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^® 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."

Posted-In: News FDA


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