Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

"The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes.~The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter~* IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher.~* Cool Point™ Irrigation Pump~* Cool Point™ Tubing set~* Data Logger"