(By Balaseshan) Endologix Inc. (NASDAQ: ELGX), which develops medical devices to treat aortic disorders, said its IntuiTrak Delivery System received Shonin approval for marketing in Japan.
The company said 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.
[Related -Ports In A Storm - Best Performing Stocks During This Down Movement]
IntuiTrak 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 30,000 AAA's worldwide with very positive physician acceptance.
"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," said Bob Mitchell, President, International of Endologix.
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 about 75%, making it a leading cause of death in the U.S.
[Related -Positive Close With Strong Technicals]
In a separate release, Endologix said it has become aware that Lifeport Sciences, LLC, which is affiliated with Acacia Research Corp., has filed a lawsuit against the company in the U.S. District Court in Delaware alleging that Endologix's AFX Endovascular AAA System and IntuiTrak Powerlink System infringe five of Lifeport's U.S. patents. The five patents are scheduled to expire on various dates between 2013 and 2015.
ELGX is trading up 0.50% at $14.10 on Monday. The stock has been trading between $11.15 and $15.77 for the past 52 weeks.