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 diagnose a wide range of arrhythmias.1,2,**

Systems Prod EnSite Precision Map
EnSite_Precision™_cardiac_mapping_system
ENSITE PRECISION™ CARDIAC MAPPING SYSTEM

Drs. Gerhard Hindricks and Philipp Sommer of the University of Leipzig Heart Center reflect on their use of the EnSite Precision cardiac mapping system, and discuss key features and benefits while showing the system in action.

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

EnSite Precision™ Link, Sensor Enabled™

System Prod EnSite base

EnSite Precision™ Field Frame with Field Frame Mounting Bracket and Field Frame Cable

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 module3
  • Achieve fast, real-time contact force measurements using the TactiCath™ Quartz contact force ablation catheter
  • 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 modeling4,5
BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The EnSite Precision™ cardiac mapping system is one of our featured electrophysiology products. We are leading the way with inventive designs that give you the options you need to diagnose, treat and manage arrhythmias with versatility and effectiveness. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Read more about our approach to cardiac arrhythmias management.

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)

Accuracy of the Ensite™ NAVX™ Navigation and Visualization Technology, Sensor Enabled™

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 L.M., 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 Cardiovascular Electrophysiology, 29 (1), 186-195. https://dx.doi.org/10.111/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
5. Abbott. Data on file. Report 90114565.

 

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.1,2**

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 offer3:
    — 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 modeling6,8
  • 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 with any catheter***1
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.

We are leading the way with inventive designs that give you the options you need to diagnose, treat and manage arrhythmias with versatility and effectiveness. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Read more about our approach to cardiac arrhythmias management.

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 90213771.
4. St. Jude Medical. Data on file, Report 90214738.
5. St. Jude Medical. Data on file, Report 90202460.
6. St. Jude Medical. Data on file, Report 90114565.
7. 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
8. 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

ENSITE PRECISION™ CARDIAC MAPPING SYSTEM

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.

TECHNICAL SPECIFICATIONS

Reorder Number

Description

 

H702496

EnSite Precision™ Module Software

H702470

EnSite Precision™ Module Hardware

EN0020-P

EnSite Precision™ Surface Electrode Kit

H702498

EnSite™ AutoMap Module v.1.0

H702500

EnSite™ Contact Force Module v.2.0

EC1000

EnSite™ Array™ Catheter

AM901

EnSite Precision™ System Assurance Plus Plan

See full product details

IMPORTANT SAFETY INFORMATION
INDICATIONS, SAFETY & WARNINGS

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: 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.

Warnings: Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

Precautions: Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision Field Frame cable. If placed this close—particularly if the cables are parallel to each other—the tool cable may become subject to electromagnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.

SJM-CV WEB-0718-0028(2)

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