Device Dossier
FlexAbility Ablation Catheter with Bi-Directional Handle - Cardiac radio-frequency ablation system catheter
Device Dossier for FlexAbility Ablation Catheter with Bi-Directional Handle - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency…
- GMDN category: Cardiac radio-frequency ablation system catheter
Intended purpose
The FlexAbility Ablation Catheter is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of arrhythmias. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.
Functional description
Catheter is constructed of thermoplastic elastomer material and noble metal electrodes with a flexible tip electrode. It has fluid lumen connected to open conduits at the flexible tip electrode for saline irrigation during the ablation procedure. The tip curvature is manipulated by the control mechanism located on the handle at the catheter’s proximal end. To adjust the curve of the distal tip on the bi-directional catheter, use the actuator to deflect the catheter in either direction.