EPT-10887_03/09 © 2009 Boston Scientific Corporation or its affiliates. All rights reserved....
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Transcript of EPT-10887_03/09 © 2009 Boston Scientific Corporation or its affiliates. All rights reserved....
EPT-10887_03/09
© 2009 Boston Scientific Corporation or its affiliates. All rights reserved.
Performance always matters.Performance always matters.
Blazer™ Dx-20 Diagnostic CatheterBidirectional Duodecapolar Diagnostic Catheter on the Blazer Catheter Platform
In-Service Presentation
EPT-10887_03/09 Performance always matters.Performance always matters.2
Blazer™ Dx-20 CatheterProduct DescriptionBlazer™ Dx-20 CatheterProduct Description
Bidirectional Duodecapolar Diagnostic Catheter on the Blazer™ Catheter Platform
• 20 electrodes on soft, extended distal tip
• Size: 7Fr
• 2 curve options• Super Large and Medium Curve• Wide range of electrode spacing options
• Single Cable Connection
• Clinical Applications• Map AFL circuit • Verify bidirectional block
EPT-10887_03/09 Performance always matters.Performance always matters.3
Blazer™ Dx-20 CatheterProduct SpecificationsBlazer™ Dx-20 CatheterProduct Specifications
Blazer Dx-20 Catheter• 20 electrodes on extended distal tip
– Distal tip length = 21 cm
• Tip Electrode Length = 2.0 mm• Ring Electrode Length = 1.2 mm• Curve Options
– Super Large Curve = 56 mm– Medium Curve = 25 mm
• Useable Length – Super Large Curve = 100 cm– Medium Curve = 109 cm
Cable• Single quick connect cable connection with 20 pins• Cable Length = 1.5 meters.• Single-use only at launch
– 10x resterilizeable by EtO & Sterrad
EPT-10887_03/09 Performance always matters.Performance always matters.4
Blazer™ DX-20 CatheterCurve OptionsBlazer™ DX-20 CatheterCurve Options
Standard Placement (PA View)(Super Large Curve)
CoronarySinus
RALateralWall
LeftAtrium
Super Large Curve• Diameter = 56 mm
– Comparable to competitive duodecapolar Dx catheters
• Catheter introduction and placement similar to “traditional” duodecapolar Dx catheters
Blazer Dx-20Super Large Curve
56 mm
EPT-10887_03/09 Performance always matters.Performance always matters.5
Blazer™ DX-20 CatheterCurve OptionsBlazer™ DX-20 CatheterCurve Options
Medium Curve• Diameter = 25 mm
– Diameter optimized for CS access
• Design features assist in catheter introduction and placement
• One Dx catheter for recording along RA lateral wall and in CS
– Reduces # of Dx catheters in RA
• Isthmus region left unobstructed for AFL ablation
Alternative CS_RA Placement (PA View)(Medium Curve)
CoronarySinus
RALateralWall
LeftAtrium
Unobstructedisthmus region
One catheter records RA
and CS
Blazer Dx-20Medium Curve
25 mm
EPT-10887_03/09 Performance always matters.Performance always matters.6
Demonstration of Blazer™ Dx-20 CatheterSuper Large & Medium Curves
EPT-10887_03/09 Performance always matters.Performance always matters.7
Blazer™ Dx-20 CatheterHandle & Packaging DifferentiatorsBlazer™ Dx-20 CatheterHandle & Packaging Differentiators
It’s Blue
Tactile Features
Integrated ConnectorColor BandNew Icons
Package has color differentiation for easy differentiation from ablation
catheter packaging
Blazer Dx-20 Catheter Packaging
Product i.d. information on reverse side
Blazer Dx-20 Catheter Handle
Handle has color and tactile differentiators for easy differentiation
from Rx catheter handle
EPT-10887_03/09 Performance always matters.Performance always matters.8
Blazer™ Dx-20 CatheterCatheter Product Labeling Blazer™ Dx-20 CatheterCatheter Product Labeling
Schematic with electrode spacing, curve dimension, tip size, and useable length
Circle design element contains shaft & tip
size
End Panel
Front Panel
Side Panel
Fold Over
Fold Over
Note: Pouch label identical to carton label, but without end and back panels and with purple color treatment
Key information presented on
side panel
Product name and description
Key information presented on
end panel
Peel-off labels for patient chart
EPT-10887_03/09 Performance always matters.Performance always matters.9
• Single cable connection with 20 pins
• Cable Length = 1.5 meters
• Single-use only at initial launch– 10x resterilizeable by EtO & Sterrad
• Simplified catheter-to-cable connection– Catheter & cable alignment markings (dots)– Color coding and labeling of pin-out connections
• New packaging for easy product identification
Blazer™ Dx-20 CatheterCable Packaging & ConnectionsBlazer™ Dx-20 CatheterCable Packaging & Connections
Single Connector Quick Connect Cable
EPT-10887_03/09 Performance always matters.Performance always matters.10
Blazer™ Dx-20 CatheterCable Product Labeling Blazer™ Dx-20 CatheterCable Product Labeling
Product name and description
Schematic with cable length
Peel-off labels for patient chart
Note: Pouch label identical to carton label, but without end and back panels
Front Panel
End Panel
Back Panel
Key information presented on
end panel
Fold Over
Fold Over
EPT-10887_03/09 Performance always matters.Performance always matters.11
Blazer™ Dx-20 CatheterModel NumbersBlazer™ Dx-20 CatheterModel Numbers
Model Number Curve Electrode Spacing
M004 20SL222 0 Super Large 2/2/2mm
M004 20SL555 0 Super Large 5/5/5mm
M004 20SL252 0 Super Large 2/5/2mm
M004 20SL282 0 Super Large 2/8/2mm
M004 20SL2102 0 Super Large 2/10/2mm
M004 20SL2860 0 Super Large 2/8/2/8/2/8/2/8/2/60/2/8/2/8/2/8/2/8/2mm
M004 20SL22025 0 Super Large 2/20/2/2/2/2/2/2/2/2/2/2/2/25/2/25/2/25/2mm
M004 20M222 0 Medium 2/2/2mm
M004 20M252 0 Medium 2/5/2mm
M004 20M25505 0 Medium 2/5/2/5/2/5/2/5/2/50/5/5/5/5/5/5/5/5/5mm
M004 20M27028 0 Medium 2/2/2/2/2/2/2/2/2/70/2/8/2/8/2/8/2/8/2mm
M004 20M5405 0 Medium 5/5/5/5/5/5/5/5/5/40/5/5/5/5/5/5/5/5/5mm
M004 20M2840 0 Medium 2/8/2/8/2/8/2/8/2/40/2/8/2/8/2/8/2/8/2mm
M004 20M21035 0 Medium 2/10/2/10/2/10/2/10/2/35/2/10/2/10/2/10/2/10/2mm
M004 20S 0 (cable) N/A N/A