Magellan Robotic System
Magellan Robotic System

Hansen Medical Magellan™ Robotic System

Indications for Use

The Hansen Medical Magellan™ Robotic System, Hansen Medical Magellan Robotic Catheter and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

Important Safety Information

As with most invasive procedures, use of the Magellan Robotic System is not without risk. Serious adverse events, some of which can be fatal, may occur, including vascular damage, embolization and stroke. Other potential risks inherent to procedures such as this include loss of limb, catheter entrapment, infection and access site complications (e.g. 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.

Rx Only Rev:0812

Sensei X Robotic System

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 Sensei System 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:0812

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