In this interview we speak with Eric Le Royer, President and Chief Executive Officer of Endosense, to learn more about the launch of the TOCCASTAR IDE study of the TactiCath force-sensing ablation catheter. The first patient in the study was enrolled in January 2011 at Na Homolce Hospital, Prague, Czech Republic, by Petr Neuzil, MD. Tell us about the purpose of the TOCCASTAR study. What are the primary endpoints? The TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) study is the first FDA approved study of a force-sensing ablation catheter. The Principal Investigator is Vivek Reddy, MD, Mount Sinai Hospital, New York. The study will evaluate Endosense’s force-sensing TactiCath as compared with a catheter approved by the FDA for paroxysmal AF, on a randomized, one-to-one basis. The primary endpoints will be safety and effectiveness up to one year. Endosense will use the results of the study to support a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). Where will enrollment take place? How many are expected to be enrolled? The study will take place in up to 30 centers in Europe and the U.S., and we plan to enroll approximately 300 patients. Tell us about the second generation TactiCath launched in April 2010, including its enhanced features and the TactiSys system. The second generation catheter approved in Europe in the first part of 2010 was the product that we released commercially with our partner biotronik. We made some enhancements to the first generation device that was used in the pivotal trial and granted CE mark in Europe. These enhancements included changes to the catheter design to help increase ease of use and enable physicians to complete atrial fibrillation procedures with a catheter that is considered truly state of the art. However, the force-sensing technology is identical in terms of its sensitivity and the performance for the physician. Tell us about the value of force-sensing catheters. How could this technology change the catheter ablation practice? At this time physicians do not have a very good appreciation about the interface between the catheter tip and the cardiac wall, despite all the diagnostic tools that are at their disposable, whether it’s electrocardiograms, imaging modalities or three-dimensional mapping. Physicians face the dilemma between insufficient contact force and excessive contact force. With insufficient contact force, the physician will create a sort of suboptimal lesion, and we’ve seen that about half of these patients that undergo an ablation procedure will have a recurrent event within 3-12 months. Based on data that we’ve collected, we believe that the control of force will enable physicians to better control lesions, reduce the number of re-interventions, and lead overall to a better patient outcome. Key complications involving excessive contact include the risk of steam pops and tamponade, and during ablation, the physician could create some damage on the peripheral tissues such as the esophagus. Fortunately these instances are extremely rare, but they are active possibilities, and as such, physicians will want to avoid such complications. The force-sensing catheter will enable physicians to better control force, and in the process, create better lesions, and we believe this technology has the potential to enable physicians to treat patients more effectively during the first procedure with fewer complications. Tell us about Endosense’s joint development project with Siemens to integrate the contact-force data provided by the TactiCath with Siemens’ EP solutions. How will this benefit electrophysiologists in clinical practice? We believe that the control of force with improved image modalities will enable the physician to carry out the procedure in the most effective and efficient way. That is why we are working with Siemens on a research and development level, to see how the combined technologies — meaning Endosense’s force-sensing technology and the enhanced image modalities of Siemens — can create an experience where the physician can not only better understand the interface between the catheter and the cardiac wall, but do so in an optimum way in the left atrium to treat atrial fibrillation. We think that this would be a promising development, and that the combined information will make these systems easier to use and more effective and efficient down the road. When is the expected completion date for the study? How soon could we see premarket approval from the U.S. FDA for clearance of the TactiCath catheter and TactiSys system? While we cannot speak for the FDA in terms of potential timing for a U.S. device clearance, we can look to other devices the FDA has cleared for treating AF to set benchmarks. There are only 2 ablation devices that have been approved by the FDA for the treatment of atrial fibrillation; one is Biosense Webster’s NaviStar® ThermoCool® Catheter and the other is Medtronic’s Arctic Front® Cardiac CryoAblation Catheter. For each of these devices, it took about 4-5 years from first patient to approval, and the only thing I can say is that at this stage is I think we can do better than that. Is there anything else you’d like to add? I just want to highlight that Endosense has been exhibiting great progress over the years; we’ve grown from our roots as a startup company to bring real innovation to the field of atrial fibrillation. More importantly, the fact that electrophysiologists around Europe have chosen our product to treat their patients in their daily practice is the best testimony of our impact on the field of ablation of atrial fibrillation. We believe that force-sensing technology will ultimately become the standard of care as it relates to the treatment of atrial fibrillation patients in the future. We are very excited with the start of the TOCCASTAR study, which will bring a new level of maturity for an organization of our size. I believe we are among only 3 other companies that have a catheter for AF either currently approved or in development, the other 3 being brand name device companies Biosense Webster (a Johnson & Johnson company), Medtronic and St. Jude Medical. We are pleased to be so well positioned in this kind of company."
The TactiCath is currently not available in the United States.
For more information, please visit www.endosense.com