Gore Gets 510(k) Clearance of Molding and Occlusion Balloon

The FDA cleared Gore’s molding and occlusion balloon device, a compliant polyurethane balloon catheter.

The device meets all endovascular aortic repair procedural requirements, from 10 to 37 mm device sizes, and consists of a single balloon, removing the need for multiple molding and occlusion balloons.

It comes in a single catheter length of 90 mm for use with Gore Excluder devices and is designed to help clinicians with the expansion of self-expanding stent grafts and the temporary occlusion of large-diameter vessels. It is also compatible with 108 cm length guidewire.