Hansen Medical Launches the Sensei X2 Robotic System

October 30, 2014—Hansen Medical, Inc. announced that the company’s Sensei X2 robotic system is commercially available in the United States and European Union. The Sensei X2 robotic system is used during electrophysiology procedures to remotely navigate a robotic catheter in the heart atria. The Sensei system provides 3D catheter control and 3D visualization during these procedures.

The company stated that the improvements in this third-generation Sensei system include faster processing speeds, enhanced image integration, and a lower-profile design. The Sensei technology provides catheter stability, accuracy, and access to hard-to-reach areas of the atria. Sensei’s remote workstation integrates multiple imaging sources used by the physician during electrophysiology procedures.

In the United States, the Hansen Medical Sensei robotic system and accessories are indicated for use in facilitating the manipulation, positioning, and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electroanatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx steerable diagnostic catheters made by Boston Scientific Corporation and the Livewire electrophysiology catheters made by St. Jude Medical.

The company advised that the safety and effectiveness of this device for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established in the United States.

The Sensei system’s indications for use in the European Union are to control catheters and accessories that are intended to facilitate manipulation, precise positioning, and control of percutaneous catheters within the atria of the heart.

According to Hansen Medical, this technology has been evaluated in 26 studies composed of more than 2,700 patients. The clinical evidence has shown that use of the Sensei system provides low complication rates, high average contact force, catheter stability, and reduced fluoroscopy time when compared with manual procedures. Additionally, use of Sensei has been demonstrated to reduce fluoroscopy radiation exposure during left atrial electrophysiology procedures.