The FDA granted pre-market approval to St. Jude Medical for the company’s Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters and the matching IBI1500T9-CP V1.6 generator to power them.
The catheters provide cooling irrigation all around the tip from a dozen ports so that only targeted tissue is destroyed. The system is already cleared for marketing in Europe.
Some of the features:
- Externally irrigated ablation catheter with additional irrigation ports for more uniform cooling
- Lower average measured tip temperature at equivalent flow rates compared to distal tip irrigation only
- Fewer incidences of coagulum and charring observed in preliminary study
- All-braided construction provides uninterrupted torque transfer for more responsive handling
- M, L, XL, and L1 curve configurations
FDA Device Approvals and Clearances announcement: Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator