Device Dossier
FlexAbility Ablation Catheter with Bi-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter
Device Dossier for FlexAbility Ablation Catheter with Bi-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter (Cardiac…
- GMDN category: Cardiac radio-frequency ablation system catheter
Intended purpose
The FlexAbility Ablation Catheter, Sensor Enabled 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. Sensor Enabled™ Ablation Catheters are used with compatible magnetic tracking systems to enable catheter positioning and navigation. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.
Functional description
Catheter is made of thermoplastic elastomer material and noble metal electrodes, has a flexible tip electrode and magnetic sensor. A fluid lumen connects 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.