Endosense wins CE Mark for TactiCath ablation catheter

The first force-sensing ablation catheter developed worldwide, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure, said Endosense.

The CE Mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium. The CE Mark for TactiCath was granted based on select data submitted from Endosense’s Toccata 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.

Eric Le Royer, president and CEO of Endosense, said: “The CE Mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias.

“With its unique ability to measure contact force, we expect the TactiCath to have a major positive impact on the safety and efficacy of catheter ablation, while also standardizing ablation techniques and decreasing the learning curve.”