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The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated. • When used with the EnSite® Catheter, the EnSite 3000® System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR • When used with the EnSite NavX™ Surface Electrode Kit, the EnSite 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters

The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSite® Catheter, the EnSite 3000® System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with the EnSite NavX™ Surface Electrode Kit, the EnSite 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters

The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated. - When used with the EnSite® Catheter, the EnSite 3000® System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR - When used with the EnSite NavX™ Surface Electrode Kit, the EnSite 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters

The EnSite® Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

The EnSite 3000 System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000 Electrophysiology Workstation connected to the EnSite Catheter utilizes proprietary software algorithms to reconstruct and display right atrial electrograms detected by the EnSite Catheter. This information can be presented as color-coded three-dimensional maps to provide global electrical activation patterns of the heart chamber. The EnSite 3000 System may also be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads, and other analog or digital inputs. The EnSite 3000 System also incorporates a navigational tool to provide real-time feedback regarding the position of an auxiliary catheter for creation of a geometrical model of the heart chamber or for guiding therapy to a designated location.

The EnStylet™ EC0010/20 is intended for use in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System. The EnStylet™ is designed to provide deflection and positioning of the distal end of the catheter.

The EnStylet™ EC0010/20 is a pre-formed J-shaped or straight, ball-tipped, 0.027-inch diameter stainless steel wire designed to be used in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System.

The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

EnSite 3000® System Components EnSite® Multi-electrode Diagnostic Catheter The EnSite® Multi-electrode Diagnostic Catheter (EnSite® catheter) is a single use, 9 French, percutaneous catheter. The EnSite® catheter is designed for use only with the EnSite 3000® System in an electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces. EnSite 3000® Electrophysiology Workstation The EnSite 3000® Electrophysiology Workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multi-electrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac clectrograms. The EnSite 3000® may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs. The EnSite 3000® System is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.

The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

EnSite 3000 System Components EnSite Multi-electrode Diagnostic Catheter The EnSite Multi-electrode Diagnostic Catheter (EnSite catheter) is a single use, 9 French, percutaneous catheter. The EnSite catheter is designed for use only with the EnSite 3000 electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces. EnSite 3000 electrophysiology workstation The EnSite 3000 electrophysiology workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multielectrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac electrograms. The EnSite 3000 may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs. The EnSite 3000 is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.