Tell us about the Catheter Robotics Manipulation System by CRI. What are the key features?
The Catheter Robotics Manipulation System (Figure 1) design was based on the following principles:
• The system allows remote manipulation of conventional, commercially-available EP catheters;
• The remote control fully replicates the functions of the catheter handle;
• No part of the robotic system enters the patient’s body;
• The EP catheter enters the vasculature through a standard, commercially-available sheath-introducer in the groin;
• At any point in a procedure, the catheter can be removed from the robotic system, manipulated manually and then placed back into the system for further remote manipulation; and,
• All force is applied to the catheter through the handle, just as if it were held by the operator’s hand.

The system is based on a remote control handle that allows manipulation and positioning of the tip of a catheter at the target location, thus eliminating the necessity for the operator to remain in close proximity to the fluoroscope. This is important since EP studies can be lengthy, occasionally exceeding 4-6 hours, with significant fluoroscopy times. With remote manipulation using this system, the operator can have full control of catheter navigation without being in the x-ray field.
The system is comprised of a remote catheter manipulator (robot) with a remote control handle, which enables the user to control the robot that manipulates a standard EP catheter into 3 degrees: insertion and withdrawal; deflection; and rotation. The remote device replicates manual manipulation of the catheter handle and its various controls, allowing the physician using the remote control handle to remain out of the fluoroscopy field while still being able to accomplish the standard catheter maneuvers necessary to perform an EP study. In addition, at any point during the EP procedure, the operator can remove the catheter from the robot and manipulate it manually. The catheter can then be re-attached to the robot, and remote manipulation is resumed, all without breaking sterility.

The system also does not require a special sheath introducer or sheath system; it is designed to manipulate catheters inserted through any standard introducer sheath. The system is designed to also manipulate any commercially available EP catheter; therefore, no special catheters are required.
In addition, with the CRI system the catheter functions as if it was being manipulated by hand; therefore, if too much force is applied, it will buckle, just the same as it would during manual manipulation. In addition, the system does not change the normal catheter forces within the heart because the force is applied to the catheter from outside of the body, the same as with manual manipulation.
Finally, robotic systems to date have been characterized by a high price tag coupled with the use of expensive and frequently limited disposable sheaths and catheters. This CRI system may be able to provide a less costly alternative while at the same time not limit a physician’s choice of sheaths and catheters.

Can you tell us about the initial use of this system?
In a series of animal studies we conducted, we were able to position the remotely manipulated catheter in close approximation to the catheter tip of the manually manipulated catheter, usually within 3-7 mm. Adequate tissue contact was achieved based on pacing thresholds obtained from both catheters. Additionally, equivalent His bundle recordings were obtained with robotic 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.

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 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.

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).