Device Dossier

OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use

Device Dossier for OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac…

Intended purpose

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Functional description

Catheter enables electrophysiological mapping of heart with CARTO3 System. Access via 8.5F guiding sheath. Bidirectional deflectable catheter:6 parallel spines joined form 3 loops on deflectable tip. Each spine has active electrodes that form grid, for stimulating & recording. 8 platinum electrode/spine equals 6x8 electrode grid; 6 platinum electrode/spine equals 6x6 electrode grid. Sensor in deflectable tip transmits location info & electrodes below the spine allow tip visualization on CARTO

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