Gore C3 Delivery System Approved in Japan

December 3, 2013—Gore & Associates (Flagstaff, AZ) announced that it has received Shonin regulatory approval from the Japanese Ministry of Health, Labor and Welfare to market the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis featuring the Gore C3 delivery system as a minimally invasive treatment for AAA patients.

According to the company, the Gore C3 delivery system enables interventionists to reposition the Gore Excluder device before final release from the delivery catheter. The added deployment control provides physicians with increased confidence in treating challenging anatomies, as well as cannulation options with the ability to bring the contralateral gate to the contralateral guidewire.

The company stated that the Gore Excluder device remains virtually unchanged with the same low delivery profile and flexibility that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the C3 system enables intuitive repositioning of the stent graft, which may minimize complications that could occur if the stent graft needs to be repositioned after the initial deployment. The US Food and Drug Administration approved this technology in January 2011.

In Gore’s press release, Alan Lumsden, MD, commented, “The Gore C3 delivery system offers more opportunities to optimize infrarenal seal and provides the physician with greater control. The ability to reposition minimizes complications that can occur with graft placement, adding a level of confidence and control during endovascular procedures that physicians have not experienced before.” Dr. Lumsden is Chair, Department of Cardiovascular Surgery at the Methodist Hospital in Houston, Texas.