FDA Approves Gore C3 Delivery System

January 4, 2011—Gore & Associates (Flagstaff, AZ) announced that the company has received approval from the US Food and Drug Administration to market the Gore C3 delivery system to deploy the Gore Excluder AAA endoprosthesis for treating abdominal aortic aneurysms. The C3 system enables repositioning of the Excluder before final release from the delivery catheter. The device's  deployment control is designed for navigating challenging anatomies, and provides cannulation options, with the ability to bring the contralateral gate to the contralateral guidewire, the company stated.

According to the company, the Excluder device offers a low delivery profile and flexibility that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the C3 delivery system enables repositioning of the stent graft, which may minimize complications that could occur if the graft needs to be repositioned after the initial deployment. Eric Verhoeven, MD, recently performed the first procedure using the C3 delivery system in Europe.

"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," commented Dr. Verhoeven. "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."

"The Gore C3 delivery system is a significant technological advance for endovascular device deployment during treatment of aortic aneurysms," added Mark Fillinger, MD. "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."