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

W. L. Gore & Associates, Inc.Dec 3 2013

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.

"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," said Alan Lumsden, MD, Chair, Department of Cardiovascular Surgery at the Methodist Hospital, Houston, Texas.

"Since launching the GORE C3 Delivery System for the GORE EXCLUDER Device in 2011, it has shown a high level of performance, allowing physicians to achieve the best possible deployment of the stent-graft," said Ryan Takeuchi, Gore Aortic Business Leader. "Through our innovative designs and close collaboration with the endovascular community, Gore aims to bring safe and effective minimally invasive endovascular repair to patients worldwide."