Device Dossier

Crusade Catheter - Peripheral/coronary vasculature catheter, infusion

Device Dossier for Crusade Catheter - Peripheral/coronary vasculature catheter, infusion (Peripheral/coronary vasculature catheter, infusion, Class III,…

Intended purpose

The Kaneka Crusade Catheter is a micro catheter intended for use within a guiding catheter in conjuction with a steerable guide wire inserted through the monorail lumen of the Crusade Catheter in order to access discret regions of the vasculature. The main uses of the Crusade catheter are to guide and support a steerable guide wire inserted through its Over-The-Wire lumen (OTW) for guide wire crossing and insertion into a side branch; for guide wire exchange (either monorail or OTW) during Percutaneous Coronary Intervention. It is also used for delivery of a buddy wire (a second coronary guide wire) through the OTW lumen along side the existing one being used to advance balloons and stents inside the coronary arteries to enhance device delivery during Percutaneous Coronary Intervention. In addition, it is also used as an infusion catheter.

Functional description

The Crusade Catheter is intended to be used for: - guide wire support for crossing side branch - exchange of guide wires during percutaneous coronary intervention. The Crusade Catheter is a hydrophilic coated catheter with a dual lumen distal shaft and a coaxial OTW proximal shaft. The distal end bears two radiopaque markers.

TGA Public Summary