Device Dossier
Blazer Prime HTD Ablation Catheter - Catheter, cardiac, ablation
Device Dossier for Blazer Prime HTD Ablation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Boston Scientific).…
- GMDN category: Catheter, cardiac, ablation
Intended purpose
The Blazer Prime 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 PRIME HTD Ablation Catheter is a steerable, bi-directional quadripolar catheter used in radiofrequency catheter ablation (RFCA). It has two tip sizes available, 7F diameter/4mm length & 8F diameter/5mm length. The catheter utilizes a handle which controls the steering actuation and curve retention/locking functions. Ablation is conducted by applying RF power from the generator to the distal tip electrode to a target site to eliminate unwanted electrical pathways.