Device Dossier

Therapy Cool Flex Ablation Catheter - Catheter, cardiac, electrophysiological mapping

Device Dossier for Therapy Cool Flex Ablation Catheter - Catheter, cardiac, electrophysiological mapping (Catheter, cardiac, electrophysiological…

Intended purpose

Therapy Cool Flex ablation catheter is intended for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

Functional description

The Therapy Cool Flex Ablation Catheter is a flexible, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes. This catheter has a novel flexible tip electrode and interlocking grooves on the flexible tip electrode for saline irrigation during ablation with a compatible RF generator. The distal curve may be manipulated by the thumb control mechanism located in the handle at the proximal end of the catheter.

TGA Public Summary