Device Dossier
AlCath Flutter Black LT G - Catheter, cardiac, ablation
Device Dossier for AlCath Flutter Black LT G - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Biotronik). ARTG record,…
- GMDN category: Catheter, cardiac, ablation
Intended purpose
The AlCath catheter is intended as a temporary, unidirectional steerable quadripolar catheter for intracardiac RF ablation as well as for sensing of intracardiac signals and diagnostic pacing. They are intended for treatment of supraventricular, ventricular and atrioventricular cardiac tachyarrhythmia and AV node reentry tachycardia.
Functional description
Temporary unidirectional steerable quadripolar catheters for sensing of intracardiac signals and RF ablation of cardiac tachyarrhythmia. A thermocouple monitors/controls temperature during RF current ablation. Gold electrodes minimise transition resistances, maximising conductance. A deflectable tip has increased lateral stability, is softer & more flexible than in the transverse direction. Ablation in the cavo-tricuspid isthmus in the right atrium & treating atrial flutter