Device Dossier

IntellaTip MiFi Open-Irrigated Ablation Catheter - Catheter, cardiac, ablation

Device Dossier for IntellaTip MiFi Open-Irrigated Ablation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Boston…

Intended purpose

The IntellaTip MiFi OI Catheter is indicated for use in patients who require catheterbased cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a RF generator, for cardiac ablation.

Functional description

The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation. The device includes three diagnostic mini electrodes embedded in the tip electrode that are designed to provide additional high resolution and localized electrogram information.

TGA Public Summary