EnSite Precision™ Cardiac Mapping System
CARDIOVASCULAR
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AUTOMATED. FLEXIBLE. PRECISE.

The EnSite Precision™ cardiac mapping system offers next-generation technology that allows for a high level of automation, flexibility and precision to help you more effectively diagnose a wide range of arrhythmias.1,2

Systems Prod EnSite Precision Map
TRANSFORM PROCEDURES WITH INTUITIVE AUTOMATION1

Advanced mapping is complex. You need precise information quickly to make sound decisions. The EnSite Precision cardiac mapping system helps you decrease mapping time using intelligent automation tools.*1 The system:

  • Enhances VT mapping with automated, advanced morphology matching capability when using the EnSite™ AutoMap module and TurboMap feature1
  • Lets you automatically reject catheter ectopy
  • Features new timing detection algorithms including Last Deflection
  • Offers two new map types: Fractionation Map and Score Map
ENSITE™ AUTOMAP MODULE WITH AUTOMATED MORPHOLOGY MATCHING CAPABILITY
Systems Prod EnSite auto map module
EXPAND PROCEDURAL OPTIONS USING SUPERIOR FLEXIBILITY1**

EP procedures are unpredictable. You need options to tailor patient therapy and streamline workflow. The EnSite Precision cardiac mapping system is designed to help you customize your procedures to address the circumstances of each case.

  • Map any chamber with any catheter.***
  • Create faster high-density maps using any catheter.1
EFFECTIVELY MANAGE PATIENTS THROUGH GREATER PRECISION2****

Patients are unique. You need precision you can rely on. The EnSite Precision cardiac mapping system uniquely combines impedance and magnetics, so you can enhance model creation.2

System Prod EnSite Precision Link
System Prod EnSite base
LEVERAGE NEW AND EXISTING ADVANCED TECHNOLOGY

The EnSite Precision cardiac mapping system is built on an open platform, allowing you to choose the diagnostic and ablation catheters which best meet the needs of your patients.

The EnSite Precision™ cardiac mapping system also allows you to:

  • Choose contact or noncontact mapping
  • Improve model accuracy by reducing the “tenting” effect when creating a model with the ablation catheter, and minimize variation in voltage amplitude during mapping with the EnSite™ contact force module4
  • Achieve fast, real-time contact force measurements using the TactiCath™ Quartz contact force ablation catheter4
  • Use EnSite Automap module with OneModel and OneMap in one system, achieving 54% faster, real-time model creation with the OneMap tool—offering precise anatomic modeling5,6.
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The EnSite Precision™ cardiac mapping system is one of our featured electrophysiology products. Our vision is to transform the treatment of cardiac arrhythmias by designing outcome-driven and cost-effective technologies. Read more about our approach to electrophysiology

RESOURCES AND DOCUMENTATION
REFERENCES
*Comparison is versus manual mapping with EnSite Precision™ mapping module or manual lesion marking. **The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter, thus offering superior flexibility as compared to Biosense Webster’s Carto™‡ system, which limits use to Biosense Webster‡ catheters only. ***In accordance with catheter indication for use. ****Greater precision based on improvement in accuracy of impedance model with magnetic field scaling applied via robot testing vs. EnSite Velocity v4.0.2.
  1. Ptaszek LM, Moon B, Rozen G, Mahapatra S, Mansour M. (2018). Novel automated point collection software facilitates rapid, high-density electroanatomic mapping with multiple catheter types. J Cardiovasc Electrophysiol, 29(1), 186-195. https://doi.org/10.1111/jce.13368.
  2. St. Jude Medical. Data on file, Report 90237452.
  3. St. Jude Medical. Data on file, Report 90214738.
  4. Heist, E. K., Danik, S., Chalhoub, F., Koci, F., Barrett, C., Perna, F., … Mansour, M. (2011). Human and animal feasibility study of investigational 3D geometry acquisition software. Heart Rhythm, 8, S241, http://dx.doi.org/10.1016/j.hrthm.2011.03.027

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

MAP THE MOST COMPLEX CASES1

The EnSite Precision™ cardiac mapping system is designed to help you map even the most complex arrhythmia cases through a high level of automation, flexibility and precision.1

INTUITIVE AUTOMATION1

With the EnSite Precision cardiac mapping system, you can decrease mapping time using intelligent automation tools.1* With the system, you can:

  • Enhance VT mapping with automated, advanced morphology matching capability1
  • Automatically reject catheter ectopy
  • Increase procedural consistency through automated guidance of lesion marking using the AutoMark feature4
SUPERIOR FLEXIBILITY1**

EP procedures are unpredictable, and the EnSite Precision cardiac mapping system helps you customize your procedure to address the circumstance of each case.

  • Map any chamber with any catheter.***
    • Choose the workflow you need to accommodate patient needs
    • Use the system to optimally integrate magnetic and impedance data.
CREATE FASTER HIGH-DENSITY MAPS USING ANY CATHETER1
System Prod EnSite verEff
GREATER PRECISION2****

The EnSite Precision cardiac mapping system combines impedance and magnetics with a suite of innovative tools to give you comprehensive patient information.

  • Enhance model creation with both impedance-field flexibility and magnetic-field stability.2
  • Improve stability with redesigned patches that offer:3
  • Improved hydrogel adhesive3
  • Improves ECG patch placement options
  • More accommodation for patients of all sizes
  • Maintain a seamless workflow, now with greaterprecision via an automated sheath filter.4
3-D MODELS WITH CT-SCAN-LIKE DETAIL—27X† HIGHER POINT DENSITY4,7
System Prod EnSite 3D Model
IMPROVE MAPPING TIME1*

With EnSite Precision cardiac mapping system, you can:

  • Map secondary arrhythmias up to 10x faster with the TurboMap feature1
  • Have access to both positive and negative morphology matching score that may accentuate scar regions and aid in visualization of critical isthmus channels1
  • Create faster, more accurate maps with greater consistency across cases1
MAPPING TIME COMPARISON OF MANUAL, ENSITE™ AUTOMAP MODULE AND TURBOMAP1
System Prod EnSite Mapping Time Comp
POINT COLLECTION RATE (AUTOMAP VS. MANUAL) ACROSS MULTIPLE CHAMBERS1
System Prod EnSite Auto Map vs. Manual
USE ONEMODEL AND ONEMAP WITH THE ENSITE™ AUTOMAP MODULE

The OneMap and OneModel tools in the EnSite Precision cardiac mapping system can be used alongside the EnSite™ AutoMap Module for enhanced mapping capability. The EnSite Precision cardiac mapping system with the EnSite AutoMap Module lets you:

  • Achieve 54% faster, real-time model creation with the OneModel tool—offering precise anatomic modeling6,7
  • Gain visibility into a patient’s rhythm in the fewest possible cardiac cycles when using the EnSite AutoMap module with the OneMap tool—providing simultaneous collection of anatomic and electrical points from multiple electrodes6
  • Create higher density map in less time—automatically, precisely and with any catheter1,4
  • Collect data with no point limit and better trust the data collected, eliminiating time-consuming evaluation of each data point1,4
System Prod EnSite mapping points one model
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The EnSite Precision™ cardiac mapping system is one of our featured electrophysiology products. Our vision is to transform the treatment of cardiac arrhythmias by designing outcome-driven and cost-effective technologies. Read more about our approach to electrophysiology.

RESOURCES AND DOCUMENTATION
REFERENCES
*Comparison is versus manual mapping with EnSite Precision™ mapping module or manual lesion marking. **The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter, thus offering superior flexibility as compared to Biosense Webster’s Carto system, which limits use to Biosense Webster catheters only. ***In accordance with catheter indication for use. ****Greater precision based on improvement in accuracy of impedance model with magnetic field scaling applied via robot testing vs. EnSite Velocity v4.0.2. ††Based on minimum distance allowed between 3-D model points with EnSite Precision™ system (left) versus previous EnSite™ Velocity™ system (right).
  1. Ptaszek LM, Moon B, Rozen G, Mahapatra S, Mansour M. (2018). Novel automated point collection software facilitates rapid, high-density electroanatomic mapping with multiple catheter types. J Cardiovasc Electrophysiol, 29(1), 186-195. https://doi.org/10.1111/jce.13368.
  2. St. Jude Medical. Data on file, Report 90237452.
  3. St. Jude Medical. Data on file, Report 90212729.
  4. St. Jude Medical. Data on file, Report 90114565.
  5. St. Jude Medical. Data on file, Report 90214738.
  6. Heist, E. K., Perna, F., Chalhoub, F., Danik, S., Barrett, C., Houghtaling, C., … Mansour, M. (2013). Comparison of electroanatomical mapping system: Accuracy in left atrial mapping. Pacing and Clinical Electrophysiology, 36(626-631). http://dx.doi.org/10.1111/pace.12095
  7. Heist, E., Perna, F., Chalhoub, F., Danik, S., Barrett, C., Houghtaling, Mansour, M. (2013) Comparison of Electroanatomical Mapping Systems: Accuracy in Left Atrial Mapping. PACE, 36, 626-631.
ENSITE PRECISION™

Cardiac Mapping System

Ordering Information:

The EnSite Precision™ System is comprised of three groups of components; the EnSite™ Amplifier, the display workstation and the EnSite Precision™ Module. The system includes the EnSite™ Courier™ PACs Module v3.0, EnSite™ Derexi™ Module v.1.3.1, EnSite™ Verismo™ Module v.2.0.1 and EnSite™ Fusion™ Module v.7.1. Disposable components and expansion modules commonly used with the system are listed below.

  • ORDERING INFORMATION
    Reorder Number Description

    H702496

    H702470

    EN0020-P

    H702498

    H702500

    EC1000

    AM901

    EnSite Precision™ Module Software

    EnSite Precision™ Module Hardware

    EnSite Precision™ Surface Electrode Kit

    EnSite™ AutoMap Module v.1.0

    EnSite™ Contact Force Module v.2.0

    EnSite™ Array™ Catheter

    EnSite Precision™ System Assurance Plus Plan

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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Brief Summary:

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information.

  • When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping 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 an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Contraindications:

There are no known contraindications to use.

Precautions:

There are no known warnings or precautions specific to this product. Refer to the EnSite Precision™ Cardiac Mapping System Instructions for Use for warnings and precautions pertaining to the EnSite Precision™ Cardiac Mapping System.

Potential Adverse Events:

The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

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