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Click to edit Master title style Click to edit Master text styles – Second level • Third level – Fourth level AC_Presentation_Neuro. Speed_Credo_150605 » Fifth level Presentation Neuro. Speed® PTA Balloon Catheter & Credo® Stent for intracranial stenosis 1 Confidential: Internal Use only
Concept Neuro. Speed® PTA Balloon Catheter in combination with Credo® Stent Ø Flexible • PTA alone with Neuro. Speed® PTA Balloon Catheter • PTA with Neuro. Speed® PTA Balloon Catheter + Stenting with Credo® Stent through Neuro. Speed PTA Catheter Ø 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 2 Confidential: Internal Use only Safe and accurate inflation reduced snow plow effect less procedurel steps reduced procedural risks
Optimized Procedure: • Delivery of Neuro. Speed® PTA catheter • Inflation of Neuro. Speed® PTA catheter • Delivery of Credo® Stent through low profile Neuro. Speed PTA Catheter if necessary 3 Confidential: Internal Use only
Neuro. Speed® PTA Balloon Catheter Product Overview The Neuro. Speed® PTA Balloon Catheter is indicated for dilatation of a stenosis in the cerebral arteries in order to improve perfusion. Neuro. Speed® 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 4 Confidential: Internal Use only CE pe n for 1. ding 5 mm
Neuro. Speed® PTA Balloon Catheter Product Overview – Radiopaque Marker Longer soft tip for improved trackability One radiopaque marker indicating the distal tip of the catheter ( For positioning control) 5 Two radiopaque markers indicating the nominal length of the balloon Confidential: Internal Use only
Neuro. Speed® PTA Balloon Catheter Product Overview Neuro. Speed® Compliance Chart Inflation Pressure Balloon Diameter (mm) bar psi 1. 0 2. 0 3. 0 4. 0 5. 0 6. 0 7. 0 8. 0 9. 0 10. 0 11. 0 12. 0 13. 0 14. 5 1. 66 29. 0 1. 72 43. 5 1. 78 58. 0 1. 84 72. 5 1. 92 87. 0 2. 00 101. 5 2. 10 116. 0 2. 16 130. 5 2. 22 145. 0 2. 27 159. 5 2. 33 174. 0 2. 39 188. 5 2. 46 203. 0 2. 52* Nominal Pressure 6 2. 00 2. 50 3. 00 3. 50 4. 00 1. 93 2. 09 2. 22 2. 33 2. 42 2. 50 2. 59 2. 65 2. 70 2. 75 2. 82 2. 87 2. 92 2. 98* 2. 18 2. 42 2. 62 2. 78 2. 89 3. 00 3. 14 3. 22 3. 29 3. 38 3. 46 3. 54 3. 64 3. 73* 2. 97 3. 06 3. 17 3. 25 3. 39 3. 50 3. 62 3. 69 3. 76 3. 83 3. 90 3. 97* 4. 04 4. 11 2. 92 3. 26 3. 50 3. 72 3. 87 4. 00 4. 14 4. 23 4. 30 4. 37 4. 45 4. 53* 4. 62 4. 70 * Rated Burst Pressure • Adjustable diameter over pressure range but NO Dogbone Effect • Less sizes needed for comparable performance Neuro. Speed® (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 Confidential: Internal Use only
Credo® Stent Product Overview Used in combination with the Neuro. Speed® PTA balloon catheter, the Credo® stent is indicated to increase the vessel diameter of intracranial arteries (for example the ICA, MCA, VA/C 4 -BA, V 4) that are suitable for and accessible to the system (stent with PTA balloon catheter) in patients specific attributes. Credo® Stent diameter 3. 5 and 4. 5 mm Stent length 15 and 20 mm Vessel diameter 2. 0 – 4. 0 mm Delivery catheter Neuro. Speed® PTA Balloon Catheter 7 Confidential: Internal Use only CE pe n ding
Credo® Stent Product Overview 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 Concept: Gentle stent performance for stabilization of the lesion but no trauma to surronding pathologic vessel tissue 8 Confidential: Internal Use only
Credo® Stent Product Overview – Radiopaque marker concept Distal radiopaque marker of the Neuro. Speed® PTA balloon catheter for controlled Stent deployment Distal and proximal radiopaque balloon marker of the Neuro. Speed® PTA balloon catheter indicating the nominal working length of the balloon Only stent marker are visible (not the whole stent) advantage for follow-up • Barely any artefacts • Non shadowing in angiography Distal transport wire marker Credo® Stent indicating the tip of the transport wire for correct placement within the catheter 9 3 Distal X-Ray markers Credo® Stent indicating the opening of the device Central transport wire marker Credo® Stent indicating the middel of the Stent Confidential: Internal Use only Proximal transport wire marker Credo® Stent indicating the point up to which the stent can be repositioned
Procedure i. e. nominal pressure = 6 bar Pathology: symptomatic stenotic lesion Delivery of low profile Neuro. Speed® and inflation of ballon 10 Confidential: Internal Use only
Procedure If necessary CREDO® stent deployment after PTA without any exchange maneuver 11 Confidential: Internal Use only
Procedure Pathology: symptomatic stenotic lesion Delivery of low profile Neuro. Speed® and passage of lesion 12 Confidential: Internal Use only
Procedure i. e. nominal pressure = 6 bar Gentle, contrallable Inflation of the Neuro. Speed® PTA catheter 13 Confidential: Internal Use only
Procedure If necessary CREDO® stent deployment after PTA without any exchange maneuver 14 Confidential: Internal Use only
Procedure If necessary CREDO® stent deployment after deflation without any exchange maneuver 15 Confidential: Internal Use only
Treatment Concept Live presentation of the procedure … 16 Confidential: Internal Use only
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