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Confidential: Internal Use only1
Click to edit Master title style
Click to edit Master text styles– Second level
• Third level– Fourth level
» Fifth level
PresentationNeuroSpeed® PTA Balloon Catheter &Credo® Stent for intracranial stenosis
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Confidential: Internal Use only22
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
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
Confidential: Internal Use only66
Product Overview NeuroSpeed® PTA Balloon Catheter
NeuroSpeed® (4.0 x 8 mm) Diameter
PressureDogbone
(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 performanceInflationPressure
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
Confidential: Internal Use only77
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.
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 StentThe 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