Following the company’s recent FDA clearance of its Sensei Robotic Catheter System, Hansen Medical Inc., said it has now obtained European Union CE Mark approval for both the Sensei and its Artisan Control Catheter. The company can now begin marketing the system for use during electrophysiology (EP) procedures in the EU.
In April, the company announced that it had commenced shipments of two Sensei systems to its European sales distributor. One system has been installed at a customer site in the Czech Republic and the second system is expected to be installed at the customer site within the next several weeks.
The new robotic catheter navigation technology incorporates fluoroscopic, intracardiac ultrasound, 3D surface map and patient electrocardiogram data into a portable workstation.