Device Dossier
Blazer Open-Irrigated Ablation Catheter - Catheter, cardiac, ablation
Device Dossier for Blazer Open-Irrigated Ablation Catheter - Catheter, cardiac, ablation (Catheter, cardiac, ablation, Class III, sponsor Boston…
- GMDN category: Catheter, cardiac, ablation
Intended purpose
The Blazer Open-Irrigated Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation.
Functional description
The Blazer Open-Irrigated Ablation Catheter is a 7.5F quadrapolar ablation catheter designed to deliver RF energy to the 4mm tip electrode for cardiac ablation. The catheter incorporates an open-irrigated cooling mechanism through a tip that is partitioned into 2 chambers. The proximal chamber circulates saline within the tip to cool the electrode while the distal chamber allows the fluid to flow through 6 irrigation holes into the patient’s vasculature to cool the tip/tissue interface.