Device Dossier

VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter

Device Dossier for VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter (Cardiac irreversible electroporation system…

Intended purpose

The VARIPULSE™ Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a TRUPULSE™ Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO™ 3 System.

Functional description

Catheter assists mapping cardiac structures in heart, obtains electrograms, provides location, delivers pulsed field energy via 10 ring electrodes during cardiac ablation. Bi-directional deflectable segment at distal end, attached with circular tip, contains 10 ring noble metal electrodes for visualization by fluoroscopy, perforated to allow saline irrigation ablation area) expands and contracts accommodating anatomy left atrium.

TGA Public Summary