FDA approves Gore's C3 Delivery System to deploy EXCLUDER AAA Endoprosthesis

W. L. Gore & Associates (Gore) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the GORE^® C3 Delivery System to deploy the GORE^® EXCLUDER^® AAA Endoprosthesis 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 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 plus delivery options that they never had before. 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 graft needs to be repositioned after the initial deployment.

According to Dr. Mark Fillinger, Professor of Surgery and Director, Vascular Surgery Training Programs at Dartmouth-Hitchcock Medical Center in Lebanon, NH, "The GORE C3 Delivery System is a significant technological advance for endovascular device deployment during treatment of aortic aneurysms. The technology gives physicians a second or even third opportunity to get the best possible deployment of the stent graft relative to the patient's anatomy. This next generation delivery system has the potential to make endovascular repair easier in challenging anatomy."

Dr. Eric Verhoeven, who serves as Chief, Department of Vascular and Endovascular Surgery, at Klinikum Süd in Nürnberg, Germany and recently performed the first procedure using the C3 Delivery System in Europe said, "We specifically selected our initial patients with challenging necks, or with difficult iliac anatomy, to be able to use the graft to its full extent. Having the option to reposition the GORE EXCLUDER Device enabled us to treat these patients with added confidence during our initial deployment. Overall, the GORE C3 Delivery System worked as it was designed and provided unparalleled control while remaining intuitive and easy to use."

David Abeyta, Gore Aortic Business Unit Leader, commented, "The GORE C3 Delivery System for the GORE EXCLUDER Device has shown a high level of performance and has already demonstrated that it will provide physicians with added confidence and control during endovascular procedures. The GORE C3 Delivery System is yet one more excellent example of how Gore's close collaboration with the endovascular community can help to improve clinical performance and patient care."