In this interview we speak with Eric Le Royer, CEO of Endosense, about the TOCCATA (TOuCh+ for CATheter Ablation) clinical study. The purpose of this ongoing study is to evaluate the safety of the TactiCath for the treatment of atrial arrhythmias. Tell us about the TactiCath force-sensing catheter. What makes it unique from other ablation catheters? What makes it unique is the fact that the force-sensing technology is embedded in an ablation catheter, at the very tip of the catheter. The force sensor allows the electrophysiologist to accurately sense in real time the force of the catheter against the cardiac wall during an ablation procedure with high precision. The electrophysiologist is able to ensure the right amount of force exerted during the ablation procedure. What are the benefits of a such a catheter? This technology directly addresses a major clinical need. The electophysiologist, in performing ablation in a very selective and precise area of the heart with RF energy, has to frequently make a guess or estimate about how much force he or she is exerting on the cardiac wall. If it is too much force, then that could yield to complications such as tamponade (perforation). If it is too little force, then that could yield to ineffective procedures. It is really a balancing act. Unfortunately, about 20-30 percent of patients have to come back for a repeat procedure if their first one was not effective. Therefore, we believe that with the right amount of catheter force and by solving this balancing act, we can help physicians to successfully treat patients and have better patient outcomes. What arrhythmias can the TactiCath be used to treat? The TactiCath can be used for any type of arrhythmia that can currently be treated with catheter ablation; this includes atrial flutter, supraventricular tachycardia, and particularly atrial fibrillation. This could extend to ventricular tachycardias, but right now only a minority of ventricular tachycardias are treated with ablation. The TactiCath open-irrigated catheter has been designed to be similar in terms of its therapeutic and dimensional characteristics to the ablation catheters currently used for treating cardiac arrhythmias. Tell us about the TOCCATA study. How many patients have been enrolled so far? How many sites are involved? TOCCATA is a 70-patient safety study that is currently underway in eight European centers. Our goal is to gain the CE mark for the treatment of atrial arrhythmias. We expect enrollment to be complete by early 2009. We are very hopeful and expect CE mark by the second quarter of next year. How many patients have been treated so far? We have enrolled approximately 20 patients. Of the first 20 patients to be enrolled in the study, what can you tell us about their procedures? We will speak about the primary endpoint when the study is completed. I can tell you that the trial is proceeding well and the patients are being treated effectively. Will any U.S. sites be involved? Not at this time, although Dr. Vivek Reddy, who is located at the University of Miami Hospital, has come to Europe to perform a few cases in Prague. In addition, Dr. Andrea Natale from St. David’s Medical Center in Austin, Texas, plans to do a few cases in Prague. What’s on the horizon for Endosense? Are there plans for further clinical research or marketing in the U.S.? The next probable step is the successful completion of the study. This will enable us to commercialize the TactiCath in Europe. As far as plans in the United States, we plan to have a PMA study subsequent to the TOCCATA study. Some early discussions have already taken place to identify the most effective and efficient way to bring the TactiCath into the U.S. marketplace. Is there anything else you’d like to add? We have a very experienced panel of clinical investigators who are involved in this study. We are very pleased to have Professor Karl-Heinz Kuck as the TOCCATA principal investigator. Besides Prof. Kuck, we are working with investigators of high profile in the field of ablation at all eight centers in Europe. Professors Saoudi and Shah, investigators in the study, have been particularly involved in the pre-clinical evaluation of the TactiCath. I believe we will have very strong evidence not only regarding safety of this technology, but that also shows the value of force-sensing catheters. We will be in the position for the first time to provide some data that relates to the current practice of force-sensing that will have the potential to change the catheter ablation practice. Everyone is very engaged in this study — the first centers that have already used the product are showing a lot of excitement about getting this technology in their hands. Therefore, we believe the TactiCath will bring to the catheter ablation practice a very unique and useful tool to standardize the procedure and improve patient outcomes.