Device Dossier

cryoICE Cryoablation Probe - Cryosurgical unit, general-purpose

Device Dossier for cryoICE Cryoablation Probe - Cryosurgical unit, general-purpose (Cryosurgical unit, general-purpose, Class III, sponsor AA-Med). ARTG…

Intended purpose

The Cryo Ice cryo–ablation probe is indicated for use in the cryosurgical treatment of cardiac arrhythmias. The PROBE freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

Functional description

The probe has a retractable handle to expose the active probe length. Its flexible tube set allows for a tight bending radius and ergonomic handle can adjust to multiple positions. The probes have malleable aluminium alloy cryotip and different coloured rigid shaft. The CRY03 (blue shaft) requires 25% less bend force to shape than the CRY02 probe (black shaft). The probes must be used with the ArtiCure Cryo1 accessory Kit utilising the ACC2.

TGA Public Summary