Device Dossier

Blazer II XP Temperature Ablation Catheter - Catheter, cardiac, ablation

Device Dossier for Blazer II XP Temperature Ablation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Boston…

Intended purpose

The Blazer II XP 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 XP Ablation Catheter is a steerable, bi-directional quadripolar catheter used in radiofrequency catheter ablation (RFCA). The catheter is inserted into a vein/artery & can be deflected to facilitate advancement into the heart near the target tissue. The catheter accesses RF power from the cardiac ablation controller & the electrical energy sent to the electrode causes heat & changes the cellular structure to ablation or produce haemostasis along a region of the cardiac tissue.

TGA Public Summary