Device Dossier

Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter DE STSF- Uni-Directional - Cardiac irreversible electroporation system catheter

Device Dossier for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter DE STSF- Uni-Directional - Cardiac irreversible electroporation system catheter…

Intended purpose

The Biosense Webster Dual Energy THERMOCOOL SMARTTOUCH™ SF Uni-Directional Catheter is intended for catheter-based cardiac electrophysiological mapping and ablation

Functional description

The Dual Energy THERMOCOOL SMARTTOUCH™ SF Uni-Directional Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with the TRUPULSE™ Generator, for cardiac ablation. The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter provides a real-time measurement of contact force between the catheter tip and the heart wall, as well as location information when used with the CARTO™ 3 System

TGA Public Summary