Device Dossier
IntellaNav ST Ablation Catheter - Cardiac radio-frequency ablation system catheter
Device Dossier for IntellaNav ST Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system catheter,…
- GMDN category: Cardiac radio-frequency ablation system catheter
Intended purpose
Indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia - typically chronic, drug refractory atrial fibrillation
Functional description
The device is designed to allow for therapeutic ablation, intracardiac diagnostic recordings, and pacing capabilities. Its electrode segment is comprised of a radiopaque 4mm tip electrode and 3 ring electrodes. The electrodes record EGM signals for mapping electrical pathway behavior, deliver radiofrequency energy to targeted tissue for ablation, and deliver electrical stimulus for pacing. The tip electrode has an embedded temperature and a position sensor for magnetic tracking and navigation