"The robotic technology embodied in the Sensei system could fundamentally change the way physicians perform percutaneous cardiac procedures and, at the same time, lead to a greater number of physicians able to perform them", stated Frederic Moll, M.D., founder and chief executive officer of Hansen Medical Inc. "The Sensei system gives physicians the freedom to extend their reach into areas of the heart via a robotically controlled catheter that provides instinctive and deliberate catheter guidance regardless of image orientation."
The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data, and is adaptable to any existing electrophysiology (EP) procedure room. The mobile workstation, which is placed away from direct radiation, allows the physician to remain seated throughout the procedure. In addition to lessening operator fatigue, it creates a virtual shield for physicians against harmful radiation during catheter-based percutaneous EP procedures.
Clinical evaluations using the Sensei system were performed in Europe with successful outcomes. Results indicate that remote control and placement of catheters with this novel robotic catheter control system produced favourable outcomes. Andrea Natale, M.D., director for the Center for Atrial Fibrillation, director of the Electrophysiology Laboratories and head of the Section of Pacing and Electrophysiology, Cleveland Clinic Foundation, used the system during clinical evaluation on 23 patients at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic, and the Klinikum Coburg in Germany.
"In my experience, the stability of the catheter allowed us to perform diagnostic and therapeutic procedures more efficiently and effectively", stated Dr. Natale. "Moreover, the incorporation of the new Sensei system and catheter did not add time to the procedures, nor did it require increased radiation time, as would normally be expected with new technology. As a result, I would expect this new system to someday become the medical standard for catheter guidance during percutaneous procedures."
The Sensei system is designed to operate in conjunction with the Artisan Control Catheter that contains a through lumen to accommodate percutaneous catheters. The control catheter is capable of movement with six degrees of freedom, which facilitates placement of percutaneous catheters in locations that are difficult to reach.
EP procedures utilizing conventional technology require that physicians perform a series of complex manipulations at one end of a compliant catheter in an attempt to position the other end accurately within a patient's beating heart. The inherent challenges of these systems can lead to increased procedure times, repeat procedures and difficulties reaching targeted tissues with precision. The new Sensei system and the Artisan catheter may offer physicians predictable control during EP procedures.
Hansen Medical Inc., based in Mountain View, California, was founded in 2002 to develop technology for the accurate and efficient control of catheter movement in 3D spaces during percutaneous cardiac procedures. The Sensei Robotic Catheter System, including the Artisan Control Catheter, requires regulatory clearance and is not yet commercially available.