Device Dossier
Blazer II Temperature Ablation Catheter - Catheter, cardiac, ablation
Device Dossier for Blazer II Temperature Ablation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Boston…
- GMDN category: Catheter, cardiac, ablation
Intended purpose
The Blazer II Temperature Ablation Catheter is 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 Blazer II Temperature Ablation Catheter is inserted percutaneously into a vein or artery. The catheter tip can be deflected to facilitate advancement into the selected heart chamber. The catheter distal area consists of electrodes that are used for recording local electrograms for mapping electrical pathways. Ablation is conducted by applying RF power from the generator to the distal tip electrode to a target site in order to eliminate unwanted electrical pathways.