Hansen Medical Sensei® X Robotic Catheter System
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.
Indications for Use
The Hansen Medical Sensei® X Robotic Catheter System, Control Catheters and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical’s robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic 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.
Important Safety Information
As with most invasive procedures, use of the SenseiSystem is not without risk. Serious adverse events, some of which can be fatal, may occur, including cardiac perforation and stroke. Other potential risks inherent to procedures such as this include cardiac tamponade and hematoma which may require additional surgery.
Do not use the system without understanding the instructions for use. For information regarding, contraindications, warnings, precautions, adverse events, and methods of use, please see package inserts included with the product.
USA Rx Only Rev:0912