Device Dossier
Cardioblate CryoFlex Surgical Ablation Probe - Cryosurgical unit, general-purpose
Device Dossier for Cardioblate CryoFlex Surgical Ablation Probe - Cryosurgical unit, general-purpose (Cryosurgical unit, general-purpose, Class III,…
- GMDN category: Cryosurgical unit, general-purpose
Intended purpose
The Cardioblate CryoFlex probe is intended to create endocardial or epicardial transmural lesions in atrial cardiac tissue using cryoablation. Cryoablation freezes the target tissue to create an inflammatory response and cryonecrosis, which results in a lesion that blocks electrical conduction.
Functional description
The Cardioblate CryoFlex Surgical Ablation Probes in combination with the console, freezes target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis. The ablation segment of the flexible Cardioblate CryoFlex Surgical Ablation Probes can be shaped and the size of the ablation segment can be reduced by covering a portion of the ablation segment with a sheath material, which acts as an insulator.