FDA approves Gore C3 delivery system for Gore Excluder AAA endoprosthesis


Gore announced that the company has received approval from FDA to commercialise the Gore C3 delivery system to deploy the Gore Excluder AAA endoprosthesis to treat abdominal aortic aneurysm (AAA) as a minimally invasive method. The Gore C3 enables the reposition of the Gore Excluder device prior to final release from the delivery catheter. The company highlighted that 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 Excluder device does not have any changes; it remains 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 minimise complications that could occur if the graft needs to be repositioned after the initial deployment.

“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,” said Mark Fillinger, professor of Surgery and director of Vascular Surgery Training Programmes at Dartmouth-Hitchcock Medical Center in Lebanon.

A first procedure using the C3 delivery system was recently performed in Europe by Eric Verhoeven, chief of the Department of Vascular and Endovascular Surgery, at Klinikum Süd in Nürnberg, Germany, he commented “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.”