Endosense, a medical technology company focused on improving safety, accessibility and efficacy associated with catheter ablation for treating cardiac arrhythmias has launched the TactiCath 75 force-sensing ablation catheter in Europe and has released the results of the EFFICAS I clinical trial to demonstrate the effect of contact force in catheter ablation procedures.
Endosense Tacticath
The TactiCath 75 is a steerable, open irrigated radiofrequency ablation catheter that uses the force-sensingfiber optic sensor technology employed in the earlier models of the TactiCath. However, the TactiCath 75 is an 8.5 F sheath compatible catheter featuring a 75 mm long curved tip. Commercially available in Europe through Biotronik, the exclusive distributer of TactiCath for Canada, Europe, Africa, Latin America and the Middle East, the TactiCath 75 provides increased safety of cardiac ablation procedures and provides decision-making time for the physician, thus reducing duration of the procedures.
The results of the European post-market study of the TactiCath during cardiac ablation procedures, EFFICAS I, were also released by Endosense. EFFICASI is a 46-patient trial designed to determine the association between contact forces applied during pulmonary vein isolation (PVI) and the efficacy of atrial fibrillation treatment. The investigators recorded the applied contact forces while performing the procedures using the TactiCath. After a three-month period, the patients were reassessed to isolate gaps in the PVI lines. Based on the lesion formation and contact force parameters, the investigators determined that with a minimum force of 10 g and Force-Time Integral of 400 g seconds, the continuous line of ablation points achieved were more successful in electrical isolation per pulmonary vein segment. Investigators have recorded these FTI parameters and minimum force as the guidelines for the EFFICAS II clinical trial.
The President and CEO of Endosense, Jan Keltjens stated that the result of the EFFICAS study demonstrates the importance of contact-force sensing. Furthermore, the study proved that non-transmural lesions can be reduced or avoided using FTI information and force. The results of the EFFICAS II study will be announced in a few months.