Search Results

Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS. The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus. The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites using computer-controlled permanent magnets to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS. The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus. The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

The Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (a.k.a. the Niobe System) is an interventional workstation for the intravascular navigation of appropriately equipped. magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The Niobe System uses computer-controlled permanent magnets for orientating the tip of a magnetic device and employs magnetic fields only to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. The Niobe System incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS. The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus. The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

The Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (a.k.a. the Niobe System) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The Niobe System uses computer-controlled permanent magnets for orientating the tip of a magnetic device and employs magnetic fields only to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. The Niobe System incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

The Amigo™ Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of compatible percutaneous electrophysiological ablation catheters that deliver RF energy in the right atrium. Use of Amigo RCS should also be in accordance with the indications for use of compatible ablation catheters. The Amigo RCS should only be used with the Boston Scientific catheters (with the Blazer" " handle) and/or the Biosense Webster catheters (with the EZ Steer® handle) in the right atrium.

The Amigo™ Remote Catheter System (Amigo RCS) is designed to facilitate the manipulation, positioning and control of compatible cardiac electrophysiological catheters. It is designed to remotely control Boston Scientific catheters (with the Blazer™ handle) and Biosense Webster catheters (with the EZ STEER® handle). The Amigo RCS consists of four (4) main reusable, non-sterile components including the remote catheter system (sled, track, and turret), a hard-wired remote control, 100 ft extension cable, and a bridge support with rail and frame. In addition, the Amigo RCS includes three (3) sterile, single-use disposable kits including the docking station and spreader) to interface with the compatible ablation catheter, and a sterile cover kit (sled cover, turret cover, nose sleeve and side covers) and track kit (track and nosecone) used to maintain a sterile field during device use. The Amigo RCS is intended to attach to the rails of an IEC 60601-1 compliant EP bed system. The Amigo RCS only interfaces with the catheter's handle such that the Amigo RCS connects to and operates the manual handle of the compatible steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection.