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Confidential: Internal Use only 1
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Presentation
NeuroSpeed® PTA Balloon Catheter & Credo® Stent for intracranial stenosis
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Concept
NeuroSpeed® PTA Balloon Catheter in combination with Credo® Stent Flexible
• PTA alone with NeuroSpeed® PTA Balloon Catheter • PTA with NeuroSpeed® PTA Balloon Catheter + Stenting with Credo® Stent
through NeuroSpeed PTA Catheter
Gentle • Gentle compliance concept of the balloon catheter • Precise and controllable inflation behavior
• Small delivery system diameter • No exchange maneuver or additional crossing of the lesion needed
• Stent for stabilisation and additional support
Optimized stenosis treamtent
reduced snow plow effect less procedurel steps reduced procedural risks
Safe and accurate inflation
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Procedure:
• Delivery of NeuroSpeed® PTA catheter
• Inflation of NeuroSpeed® PTA catheter
• Deflation of NeuroSpeed® PTA catheter
• Delivery of Credo® Stent through low profile NeuroSpeed PTA Catheter if
necessary
Optimized Procedure
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The NeuroSpeed® PTA Balloon Catheter is indicated for dilatation of a stenosis in the cerebral arteries in order to improve perfusion.
NeuroSpeed® PTA Balloon Catheter
Product Overview
NeuroSpeed® PTA Balloon Catheter
Balloon diameter 2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm
Balloon working length 8 mm
Inner diameter 0,0165‘‘
Outer diameter (dist./ prox.) 2.7 F / 3.7 F
Usable length 150 cm
Tip length 10 mm
Tip markers / Balloon markers 1 / 2
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Product Overview – Radiopaque Marker
NeuroSpeed® PTA Balloon Catheter
Two radiopaque markers indicating the nominal length of the balloon
One radiopaque marker indicating the distal tip of the catheter ( For positioning control)
Longer soft tip for improved trackability
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Product Overview
NeuroSpeed® PTA Balloon Catheter
NeuroSpeed® (4.0 x 8 mm)
Diameter
Pressure Dogbone
(max.)
nominal
4 bar 3.40 3.72
6 bar 3.60 4.00
8 bar 3.80 4.23
10 bar 3.90 4.37
• Adjustable diameter over pressure range but NO Dogbone Effect
• Less sizes needed for comparable performance Inflation
Pressure
Balloon Diameter
(mm)
bar psi 2.00 2.50 3.00 3.50 4.00
1.0 14.5 1.66 1.93 2.18 2.97 2.92
2.0 29.0 1.72 2.09 2.42 3.06 3.26
3.0 43.5 1.78 2.22 2.62 3.17 3.50
4.0 58.0 1.84 2.33 2.78 3.25 3.72
5.0 72.5 1.92 2.42 2.89 3.39 3.87
6.0 87.0 2.00 2.50 3.00 3.50 4.00
7.0 101.5 2.10 2.59 3.14 3.62 4.14
8.0 116.0 2.16 2.65 3.22 3.69 4.23
9.0 130.5 2.22 2.70 3.29 3.76 4.30
10.0 145.0 2.27 2.75 3.38 3.83 4.37
11.0 159.5 2.33 2.82 3.46 3.90 4.45
12.0 174.0 2.39 2.87 3.54 3.97* 4.53*
13.0 188.5 2.46 2.92 3.64 4.04 4.62
14.0 203.0 2.52* 2.98* 3.73* 4.11 4.70
NeuroSpeed® Compliance Chart
Nominal Pressure * Rated Burst Pressure
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Credo® Stent
Used in combination with the NeuroSpeed® PTA balloon catheter, the Credo® stent is indicated to increase the vessel diameter of intracranial arteries (for example the ICA, MCA, VA/C4-BA, V4) that are suitable for and accessible to the system (stent with PTA balloon catheter) in patients specific attributes.
Product Overview
Credo® Stent
Stent diameter 3.5 and 4.5 mm
Stent length 15 and 20 mm
Vessel diameter 2.0 – 4.0 mm
Delivery catheter NeuroSpeed® PTA Balloon Catheter
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Credo® Stent
Product Overview
Concept: Gentle stent performance for stabilization of the lesion but no
trauma to surronding pathologic vessel tissue
Potential clinical benefits of a Nitinol self expandable Stent
The higher the compression grade the higher the force it exerts
With higher compression grade, the forces needed to further compress the stent are higher
When further compressed (higher stenosis grade) the stent affects the surrounding tissue with higher intensity
When less compressed (non stenotic section) the stent affects the surrounding tissue with lower intensity
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Credo® Stent
Product Overview – Radiopaque marker concept
Only stent marker are visible (not the whole stent) advantage for follow-up • Barely any
artefacts • Non shadowing
in angiography
3 Distal X-Ray markers Credo® Stent indicating the opening of the device
Distal transport wire marker Credo® Stent indicating the tip of the transport wire for correct placement within the catheter
Central transport wire marker Credo® Stent
indicating the middel of the Stent
Distal radiopaque marker of the NeuroSpeed® PTA balloon catheter for controlled Stent deployment
Distal and proximal radiopaque balloon marker of the NeuroSpeed® PTA balloon catheter indicating the nominal working length of the
balloon
Proximal transport wire marker Credo® Stent
indicating the point up to which the stent can be repositioned
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Procedure
Delivery of low profile NeuroSpeed® and inflation of ballon
i. e. nominal pressure = 6bar
Pathology: symptomatic stenotic lesion
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Procedure
If necessary CREDO® stent deployment after PTA without any exchange maneuver
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Procedure
Delivery of low profile NeuroSpeed® and passage of lesion
Pathology: symptomatic stenotic lesion
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Procedure
Gentle, contrallable Inflation of the NeuroSpeed® PTA catheter
i. e. nominal pressure = 6bar
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Procedure
If necessary CREDO® stent deployment after PTA without any exchange maneuver
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Procedure
If necessary CREDO® stent deployment after deflation without any exchange maneuver
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Treatment Concept
Live presentation of the procedure …