Device Dossier

Cardioblate Cryoflex Clamp and Surgical Ablation Probe - Cryosurgical unit, general-purpose

Device Dossier for Cardioblate Cryoflex Clamp and Surgical Ablation Probe - Cryosurgical unit, general-purpose (Cryosurgical unit, general-purpose, Class…

Intended purpose

The Cardioblate CryoFlex clamp and surgical ablation probe are 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 Clamp and Surgical Ablation Probe, in combination with the console, freezes target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis. The device is designed to work with the provided 10 cm probe to allow clamping of tissue. The shaft and ablation segment of the probe is inserted into the clamp so that the probe’s ablation segment fits inside the distal jaw of the clamp and the jaws are controlled by a trigger.

TGA Public Summary