Device Dossier

SwiftNINJA Steerable Coronary Microcatheter - Intravascular microflow catheter

Device Dossier for SwiftNINJA Steerable Coronary Microcatheter - Intravascular microflow catheter (Intravascular microflow catheter, Class III, sponsor…

Intended purpose

The micro catheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub selective region has been accessed, the micro catheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The micro catheter should not be used in the cerebral vessels.

Functional description

The SwiftNINJA is a microcatheter with a steerable/articulating distal tip, which is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions. The steering dial and steerable tip are connected via two operating wires on the walls of the catheter shaft with a connection point on the distal catheter. The tip direction can be locked with the steering dial lock maintaining the intended direction.

TGA Public Summary