Device Dossier

Retrograde Cardioplegia Catheter - Cannula, coronary sinus

Device Dossier for Retrograde Cardioplegia Catheter - Cannula, coronary sinus (Cannula, coronary sinus, Class III, sponsor Device Technologies). ARTG…

Intended purpose

Intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.

Functional description

Designed to deliver cardioplegia solution and to provide occlusion or venting to the coronary sinus during cardiothoracic procedures while the patient is managed using cardiopulmonary bypass. The catheter has 2 or 3 lumens to deliver solution, monitor pressure within the coronary sinus, and if a third lumen is present, it either facilitates the manually inflated balloon, or the stiffening wire. It includes a manually inflating or self-inflating smooth or textured occlusion balloon.

TGA Public Summary