Device Dossier

Carillon Curved Delivery Catheter - Catheter, intravascular, guiding

Device Dossier for Carillon Curved Delivery Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Cardiac…

Intended purpose

The Carillon Curved Delivery Catheter is a component of the CARILLON Mitral Contour System XE2 which is intended to reduce secondary mitral regurgitation within 12 months of implantation

Functional description

The Device facilitates percutaneous entry of devices for the delivery of the implant, engagement of the locking mechanism of the distal anchor, and recapture of the implant (if necessary). It is composed of a metal braid reinforced polymer sheath, luer “Y” connector, a radiopaque catheter tip and curved distal end. The straight port is used for advancement and removal of a measuring device and introduction of the implant. The side port may be used for injection of radiopaque contrast medium.

TGA Public Summary