Gore receives Shonin approval from Japan to market GORE C3 Delivery System


W. L. Gore Associates, Inc. (Gore) has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE® EXCLUDER® AAA Endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA). The GORE C3 Delivery System enables physicians and interventionalists to reposition the GORE EXCLUDER Device prior to 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 GORE C3 Delivery System provides physicians with a proven stent-graft and new delivery system, which was previously unavailable in Japan. The GORE EXCLUDER Device remains virtually unchanged—with the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the GORE C3 Delivery System uniquely and intuitively enables repositioning of the stent-graft. The ability to reposition the device may minimize complications that could occur if the stent-graft needs to be repositioned after the initial deployment. This revolutionary technology, which was approved by the US Food and Drug Administration (FDA) in January 2011, was designed to give physicians two additional opportunities to accurately place the stent-graft relative to the patient’s anatomy.