EnSite System Comparison with Carto XP

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EnSite System Comparison with Carto XP
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Why the EnSite System?

• Map any arrhythmia
• Open platform 3D navigation of ANY catheter
• Reduces fluoroscopy and procedure time1,2
• Ideal for AF ablation
• Expandable system for future applications
• Unsurpassed clinical support
• Lower procedure costs

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Feature-by-Feature Comparison
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Single-Beat Noncontact Mapping

• EnSite Array Yes
• Single-beat, global activation
• Nonsustained and unstable arrhythmias
• Displays computed unipolar or bipolar
  virtual waveforms for any map location

• Carto XP No

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Activation and Voltage Mapping

• EnSite Array and EnSite NavX Yes
• Diagnostic Landmark Mapping
• Any standard EP catheter and any electrode
• 10-beats of data permanently saved
• Can be used without chamber geometry
• Diagnostic Landmark maps identify areas of low
  voltage and activation timing

• Carto XP Yes
• Only the distal electrode from a Biosense Webster
  catheter can be used
• 10-beats of data saved only temporarily
• Electroanatomic mapping identifies areas of low
  voltage and activation timing

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Dynamic Substrate Mapping

• EnSite Array Yes
• Automatically measures substrate potential based
  on user-defined parameters
• Maps scar zones or lines of conduction block
• Allows fast and accurate creation of voltage map
  and substrate markers
• Minimizes user variability

• Carto XP No

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Respiration Compensation

• EnSite NavX Yes
• Increases procedure accuracy by minimizing the
  effects of respiration
• Easily re-applied if breathing dramatically
  changes

• Carto XP No

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Geometry Creation

• EnSite Array and EnSite NavX Yes
• Highly detailed anatomic model only one per
  procedure needed
• Realtime geometry creation from up to 20
  electrodes simultaneously
• Modest patient movement does not affect location
  technology or procedure

• Carto XP Yes
• Geometry detail tied to acquisition of activation
  timing and voltage data
• Geometry based on acquisition of one point per
  cardiac cycle
• Patient movement can disrupt the location
  technology and require that the procedure be
  re-initiated

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Compatible with Most Diagnostic and Ablation
Catheters

• EnSite Array Yes
• Simultaneously displays up to four electrodes
• EnSite NavX Yes
• Simultaneously displays up to 64 electrodes on 12
  catheters

• Carto XP No
• Limited to Biosense Webster NAVISTAR catheters
• Limited to two NAVISTAR sensors

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Used with Cryo Ablation

• EnSite NavX Yes

• Carto XP No

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Compatible with Multiple Generators

• EnSite Array and EnSite NavX Yes
• Boston Scientific EPT
• CryoCath Freezor (EnSite NavX only)
• Irvine Biomedical (where available)
• Medtronic Atakr and Atakr II
• Stockert

• Carto XP Yes, with limitations
• Stockert generator recommended
• Limitations with other generators

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Compatible with Stereotaxis Magnetic Assisted
Intervention

• EnSite Array and EnSite NavX Yes

• Carto XP No may be available in future upgrade

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EnSite System Product Pipeline
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EnSite System Version 5.1 Software

• EnSite Verismo Segmentation Tool support
• Digital Image import options
• Clinical enhancements
• Simultaneous mapping from multiple electrodes
• Single-beat data from circumferential catheters
  will facilitate faster and easier AF ablation
  procedures
• Enhanced geometry smoothing
• Drag and drop anatomic marker tool

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• EnSite Verismo Segmentation Tool for Digital
  Image Fusion
• Simple cardiac segmentation

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Segmentation

• Create 3D heart models from spiral CT or MR slice
  data
• Provide the highest resolution left atrial model
  possible
• Anatomy validation assists with pre-procedure
  planning

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EnSite Verismo Segmentation Tool

• Co-development with Mayo-Biomedical Imaging
  Resource Group
• Provides fast and easy cardiac segmentation
• Supports any brand of slice-based MR or Spiral
  CT file (DICOM3)
• Supports segmentation in EP lab or at another
  site within the hospital

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EnSite Verismo Segmentation Tool

• Load any Spiral CT or MRI file (DICOM3 format)

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Creates 3D Models

• Click on the blood pool
• 3D blood pool model appears in upper right

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Segment Further Anatomy as Needed

• Add additional objects by the same process

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Comparison of Registration Tools
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EnSite Registration Tool

• CT or MR scan registers with geometry to become
  the anatomic model
• Activation timing, voltage data, labeling are
  applied to CT/MR model
• Navigation within CT/MR model

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Registration Tools Comparison
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Registration Tools Comparison
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Registration Tool Development

• Aggressive and thorough development process in
  progress
• FDA clearance underway
• Three-stage 510K IDE study
• Retrospective human studies
• Animal studies
• Prospective human studies
• Clearance expected in 2006

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Cost Comparison Atrial Fibrillation
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Why the EnSite System?

• Map any arrhythmia
• Open platform 3D navigation of ANY catheter
• Reduces fluoroscopy and procedure time1,2
• Ideal for AF ablation
• Expandable system for future applications
• Unsurpassed clinical support
• Lower procedure costs

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Guiding the Direction of Cardiac Therapies
Thank You