Jun 15, 2007 - Hansen Medical, Inc. announced that it has shipped its first Sensei Robotic Catheter System, which received 510(k) clearance in May, and Artisan Control Catheters to the Cleveland Clinic in Ohio, where physicians plan to use the device to assist in accessing hard-to-reach anatomy within heart chambers.
The Sensei system is designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart more easily and accurately during the diagnostic phase of complex cardiac arrhythmia treatment. It is compatible with fluoroscopy, ultrasound, 3-D 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. 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.
For more information: www.hansenmedical.com.