"Since we received Food and Drug Administration (FDA) clearance in May, there has been tremendous market interest, which we believe provides us with great momentum for potential sales of the Sensei system", stated Frederic Moll, M.D., founder and chief executive officer of Hansen Medical. "We are especially pleased to be working closely with the Cleveland Clinic to gather data from clinical cases to further demonstrate the benefits of this robotically controlled catheter technology."
The Sensei System, which was also installed at two institutions in Europe - St. Mary's Hospital in London and the Institute for Clinical and Experimental Medicine in Prague, Czech Republic - has already been incorporated into clinical practice for use during the treatment of complex cardiac diseases at these institutions. The Sensei system and Artisan catheter have received CE Mark approval in the European Union for use during cardiac ablation procedures.
"We are pleased to have the Sensei system at the Cleveland Clinic", stated Dr. Natale. "I have been evaluating Hansen's system for approximately four years, and we will incorporate use of the new technology in our daily practice."
The Sensei system, which is designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during the diagnostic phase of complex cardiac arrhythmia treatment, is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The two main components that comprise the system are the Artisan control catheter and an ergonomically designed, remotely placed workstation where the physician is seated throughout each procedure. In addition to lessening operator fatigue, the remote workstation creates a virtual shield for physicians against harmful radiation.
The open architecture provided by the Sensei system, which allows the use of pre-approved catheters from third-party manufacturers, requires a labeling addition from the FDA. The addition is intended to remind physicians that the safety and effectiveness of the system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.
Hansen Medical, based in Mountain View, California, was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies. More company news is available in the VMW June 2007 article Hansen Medical launches Sensei Robotic Catheter System, teams with St. Jude Medical and receives FDA clearance for commercialization of robotic platform for catheter mapping procedures.