Device Dossier

DiamondTemp Bidirectional Ablation Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for DiamondTemp Bidirectional Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation…

Intended purpose

The intended purpose of the DiamondTemp ablation catheter is to detect electrical signals and ablate cardiac tissue.

Functional description

A sterile, single use, externally irrigated ablation catheter designed to deliver RF energy for cardiac ablation. It is used with a RF generator, connection cables, an irrigation pump, tubing set and an optional footswitch. It has steering and tension knobs that actuates the curve in either direction and lock the curve. Distal tip and ring electrodes record ECG signals for mapping and stimulus delivery. RF energy delivery by catheter tip-to-tissue contact.

TGA Public Summary