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Confidential: Internal Use only 1 Click to edit Master title style Click to edit Master text styles – Second level Third level – Fourth level » Fifth level Presentation NeuroSpeed® PTA Balloon Catheter & Credo® Stent for intracranial stenosis NeuroSpeed® PTA Balloon Catheter & Credo® Stent for intracranial stenosis AC_Presentation_NeuroSpeed_Credo_150605
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Confidential: Internal Use only 22 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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Confidential: Internal Use only 33 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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Confidential: Internal Use only 44 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 diameter2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm Balloon working length8 mm Inner diameter0,0165‘‘ Outer diameter (dist./ prox.)2.7 F / 3.7 F Usable length150 cm Tip length10 mm Tip markers / Balloon markers1 / 2 CE pending for 1.5 mm CE pending for 1.5 mm
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Confidential: Internal Use only 55 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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Confidential: Internal Use only 66 Product Overview NeuroSpeed® PTA Balloon Catheter NeuroSpeed ® (4.0 x 8 mm)Diameter Pressure Dogbone (max.) nominal 4 bar3.403.72 6 bar3.604.00 8 bar3.804.23 10 bar3.904.37 Adjustable diameter over pressure range but NO Dogbone Effect Less sizes needed for comparable performance Inflation Pressure Balloon Diameter (mm) barpsi2.002.503.003.504.00 1.014.51.661.932.182.972.92 2.029.01.722.092.423.063.26 3.043.51.782.222.623.173.50 4.058.01.842.332.783.253.72 5.072.51.922.422.893.393.87 6.087.02.002.503.003.504.00 7.0101.52.102.593.143.624.14 8.0116.02.162.653.223.694.23 9.0130.52.222.703.293.764.30 10.0145.02.272.753.383.834.37 11.0159.52.332.823.463.904.45 12.0174.02.392.873.543.97*4.53* 13.0188.52.462.923.644.044.62 14.0203.02.52*2.98*3.73*4.114.70 NeuroSpeed ® Compliance Chart Nominal Pressure* Rated Burst Pressure
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Confidential: Internal Use only 77 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 diameter3.5 and 4.5 mm Stent length15 and 20 mm Vessel diameter2.0 – 4.0 mm Delivery catheterNeuroSpeed® PTA Balloon Catheter CE pending
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Confidential: Internal Use only 88 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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Confidential: Internal Use only 99 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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Confidential: Internal Use only 10 Procedure Delivery of low profile NeuroSpeed® and inflation of ballon i. e. nominal pressure = 6bar Pathology: symptomatic stenotic lesion
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Confidential: Internal Use only 11 Procedure If necessary CREDO® stent deployment after PTA without any exchange maneuver
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Confidential: Internal Use only 12 Procedure Delivery of low profile NeuroSpeed® and passage of lesion Pathology: symptomatic stenotic lesion
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Confidential: Internal Use only 13 Procedure Gentle, contrallable Inflation of the NeuroSpeed® PTA catheter i. e. nominal pressure = 6bar
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Confidential: Internal Use only 14 Procedure If necessary CREDO® stent deployment after PTA without any exchange maneuver
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Confidential: Internal Use only 15 Procedure If necessary CREDO® stent deployment after deflation without any exchange maneuver
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Confidential: Internal Use only 16 Treatment Concept Live presentation of the procedure …
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