Endosense Launches Safety Study of TactiCath System for Atrial Arrhythmias


October 9, 2008

October 9, 2008 – Endosense this week launched the TOCCATA (TOuCh for CATheter Ablation) clinical study to evaluate the safety of the TactiCath system for the treatment of atrial arrhythmias, with enrollment gaining momentum.

TOCCATA is a 70 patient European multi-center safety study. Constructed to gain the CE mark for the treatment of atrial arrhythmias, secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure.

The start of this clinical trial marks the first use of the TactiCath force-sensing catheter in patients. Ten patients have been treated so far by different investigators including Endosense European Scientific Advisors Professor Karl-Heinz Kuck, M.D., at St. Georg Hospital in Hamburg, Germany, Professor Dipen Shah, M.D., at the University Hospital of Geneva, Switzerland and Professor Nadir Saoudi, M.D., at the Princess Grace Hospital, Monaco. The patients treated to date have had different arrhythmia pathologies, including atrial fibrillation.

“The first TOCCATA patients had their arrhythmia successfully treated at acute follow-up. The physicians’ experiences have shown the tremendous potential of force-sensing to the clinical practice, and we’re hopeful that the results will reinforce our initial findings,” said Pr. Kuck, the principal investigator of TOCCATA.

TactiCath is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has the potential to impact safety and performance of the catheter ablation treatment of cardiac rhythm disorders, including atrial fibrillation (AF). AF is the most common cardiac rhythm disorder today, affecting more than 6 million people worldwide. Most AF patients are currently treated with ineffective and side effect-causing pharmaceutical drugs, with the primary alternative invasive ablation surgery. Endosense is focused on providing this sizeable patient population with a minimally invasive treatment option that is both safe and effective.

For more information: www.endosense.com