Cosmotec, a distribution partner of Endologix in Japan, has obtained Shonin approval from Japanese Ministry of Health, Labor and Welfare (MHLW) for its IntuiTrak Delivery system.
Featuring a simplified deployment mechanism and hydrophilic coating to ease access and delivery, the system delivers the Endologix’s minimally invasive Powerlink anatomical fixation stent graft for the endovascular repair of abdominal aortic aneurysms.
Endologix president Bob Mitchell said the company received positive feedback on IntuiTrak’s ease of access and the simplification of the delivery and deployment mechanism, when introduced in the US and other markets.
"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," Mitchell added.
"We are very pleased to announce the approval of IntuiTrak in Japan, which has been a very good market for our anatomical fixation technology."