Device Dossier

ThermoCool SF NAV Diagnostic/Ablation Deflectable Tip Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for ThermoCool SF NAV Diagnostic/Ablation Deflectable Tip Catheter - Cardiac radio-frequency ablation system catheter (Cardiac…

Intended purpose

The Biosense Webster ThermoCool SF NAV Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter-based cardiac electrophysiological mapping (stimulating and; recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation. Provides location information when; used with CARTO EP Navigation Systems. The Thermocool SF NAV catheter is not compatible with Carto 3 EP Navigation System prior to version 2.3

Functional description

The Catheter is a steerable multi-electrode, luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip dome electrode for ablation purposes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad. The catheter has a high torque shaft with a braided deflectable tip section containing an array of ring electrodes. Compatible to Carto EP Navigation system.

TGA Public Summary