EP Lab Digest - May 2008 - (Page 49)

MAY 2008 ON THE HORIZON 49 and with manual manipulation.There were no adverse events observed, including absence of cardiac perforation or cardiac damage indicative of the safety profile of the system. The studies also found that the catheter was easily removable from the robot seating, enabling manual manipulation if needed. Reengaging the catheter to switch back to remote navigation was simple as well. In all cases, the remote placement of catheters in both the atrium and ventricle produced pacing thresholds and electrogram recordings that were comparable to those of manually-placed catheters. Figure 2 shows the side-by-side usage of this system during the animal trials. handle (the simple control station for the system) is intuitive to the operator and requires minimal training. In addition, based on initial physician feedback, we believe that electrophysiologists around the world will ultimately enjoy this new and clearly differentiated catheter robotic system. Catheter Robotics unveiled their system at the 2008 Boston Atrial Fibrillation Symposium in January. What kind of feedback did you get? We exhibited a prototype of the CRI system at the Boston AF meeting, and gave attendees the opportunity to use the system in a simulated model (Figure 3).The overall feedback was very positive. Electrophysiologists had positive comments on the simplicity and intuitiveness of the system and the ability to use standard catheters and sheaths that they were familiar with using.They also found the small profile (especially the remote control handle) and the ability to have immediate access to the catheter for manual manipulation by easily removing the catheter from the system as significant advantages of the CRI system. In addition, they commented on their hope that the CRI system would have a lower price point than currently available robotic systems have today. For more information, please also see: Knight B, Ayers GM, Cohen TJ. Robotic positioning of standard electrophysiology catheters: A novel approach to catheter robotics. J Invasive Cardiol 2008;20:251-254. What is the current status of the device? When will clinical trials on this system begin? Also, when do you think the system might be approved for clinical use in the U.S.? We are in the process of working with the FDA with the objective of beginning clinical trials and to ultimately secure 510k clearance for the device. In addition, CRI is in the recruitment phase for the clinical sites for the human trials.The company is hopeful that the system will complete the clinical trials and receive FDA clearance in early 2009. CRI’s robotic system will also be on display at the 2008 HRS meeting in San Francisco. Could you summarize your findings regarding CRI’s system? A prototype Catheter Robotics Manipulation System used in the animal studies appeared to be safe and effective when directing EP catheters into intracardiac sites. During the conduct of the animal study, we involved a clinical electrophysiologist who used the system and provided feedback, validating the various design features. We found that the design of the system (once approved for clinical use) would indeed allow electrophysiologists the opportunity to use their standard sheaths and catheters for remote navigation and mapping during EP procedures.We were able to show that the system would also provide immediate manual access to the catheter handle during robotic manipulation without removing the catheter from the heart (a feature not currently available in any approved EP robotic systems).This “manual override” feature appears to be a very useful and attractive safety feature. The CRI control station is about the size of an ablation catheter’s handle, which is quite different than the large workstations of other robotic systems. We have also found that the ergonomic design of the remote control Disclosure: Dr.Ayers has disclosed that he is a consultant and/or paid advisory board member and has stock ownership of Catheter Robotics, Inc. (CRI). http://www.ascenths.com/cardiology http://www.ascenths.com/cardiology http://www.ascenths.com http://www.ascenths.com

Table of Contents Feed for the Digital Edition of EP Lab Digest - May 2008

EP Lab Digest - May 2008 Is There an Under-Referral of Women for Atrial Fibrillation Ablation? A Hybrid Approach to the Cure of Atrial Fibrillation Contents Letter from the Editor Spotlight Interview: University of Michigan Health System 10-Minute Interview: Amit J. Shanker, MD Modular EP Units: Are They Possible? One Hospital’s Experience All About My Job: Technician Supervisor (New Column!) Alcohol Septal Ablation in the Cath Lab: What is it All About? About the Canadian Heart Rhythm Society: Interview with Martin J. Gardner, MD, FRCP(C), FACC Email Discussion Group: May 2008 Second Annual Salary Survey My First Year in Electrophysiology: What Have I Got Myself Into? Highlight on Technology: Video-Audio Integration for the EP Lab On the Horizon: A New Remote Catheter Manipulation System Striving for Excellence in the Care of Cardiac Patients Five Reasons to Participate with a Professional Organization Suspected Shunting of Defibrillation Energy in the EP Lab Can Digital Music Players Cause Interference with Implantable Devices? ECG 101: Ambulatory ECG Monitoring Events Calendar Industry News and Products Classifieds Advertisers Index

EP Lab Digest - May 2008

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