Endosense, a medical technology company focused on the treatment of cardiac arrhythmias, has received the CE mark for its TactiCath system in the treatment of supraventricular tachycardia (SVT) of the right atrium.
The force-sensing ablation catheter TactiCath gives physicians an objective measure of contact force during the catheter ablation procedure.
The CE mark for TactiCath was granted based on select data submitted from Endosense's TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by 17 investigators at eight European centers. During procedures on 42 enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached, according to the Geneva-based company. Endosense said it plans to release the TactiCath system in Europe in the second half of 2009.