Device Dossier

Freezor Cardiac CryoAblation Catheter - Catheter, cardiac, ablation

Device Dossier for Freezor Cardiac CryoAblation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Medtronic). ARTG…

Intended purpose

The device is intended for use in the treatment of cardiac arrhythmias

Functional description

The Freezor is a flexible and steerable catheter with a tip that reaches temperatures as cold as -75 degrees C/-88degrees C when refrigerant is injected from the console to the tip. The device tip has an integrated thermocouple for temperature monitoring. Electrodes at the tip surface provide temperature and ECG reading capabilities. The catheter tip freezes heart tissue to create an ablation line to restrict electrical conduction in the heart (Atrial Fibrillation or Atrial Flutter).

TGA Public Summary