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alco • advanced lightweight constructions • GmbH |
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The first sirolimus eluting PTCA catheter with
ultra low crossing profile and high pressure capability |
PRODUCT DETAILS
Drug product: A conformal coating of a polymer carrier
loaded with 1.4 µg sirolimus / mm2 balloon
surface.
Double lumen PTCA for rapid exchange use with a
semi-compliant balloon.
Two radio-opaque markers, proximal and distal.
140 cm working length, 25 cm from tip.
Nominal inflation pressure at 8 atm.
Rated Burst Inflation Pressure at 16 atm
/ 14 atm for 3.50 mm @ L > 35 mm and for 4.00 mm @
L > 30 mm.
0.017” average crossing profile.
0.058” min. guiding catheter I.D., 0.014” max. guide wire O.D.
Technical specifications
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Type of catheter design |
Double lumen PTCA catheter |
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Drug Product |
A conformal coating of a polymer carrier loaded with 1,4 µg Sirolimus/mm2
applied to the Balloon |
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Catheter design details |
Rapid exchange, 140 cm working length, 25 cm from tip |
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Balloon type |
semi-compliant |
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Balloon folding |
Three-folding |
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Proximal shaft |
1.95 F |
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Distal shaft |
2.70F |
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Radio markers |
Femoral and brachial markers |
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Standard lengths |
8/9/10/12/14/15/16/18/20/22/24/25/30/33/35/40 mm, other length on
demand |
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Expansion range |
1.5/2.0/2.25/2.5/2.75/3.0/3.25/3.5/4.0 mm other diameters
on demand |
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Nominal inflation pressure |
8 atm (0.8 MPa) |
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Rated burst inflation pressure |
16 atm (1.6 MPa) 14 atm (1.4 MPa) for ∅ 3.50 mm @ L > 35 mm and ∅ 3.75 mm @ L > 35 mm 14 atm (1.4 MPa) for ∅ 4.00 mm @ L > 30 mm |
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Flexibility |
Excellent |
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Average crossing profile |
0.017" (0.43 mm) |
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Min. guiding catheter I.D. |
0.058” (1.47 mm) |
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Max. guide wire O.D. |
0.014” (0.36 mm) |
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Storage |
Store in a dry place below 40º C Keep away from light |
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Sterilization |
Ethylene oxide gas (ETO) |
Order-Number
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Balloon Diameter [mm] |
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1.50 |
2.00 |
2.25 |
2.50 |
2.75 |
3.00 |
3.25 |
3.50 |
4.00 |
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Balloon Length [mm] |
8 |
AX0815r |
AX0820r |
AX08225r |
AX0825r |
AX08275r |
AX0830r |
AX08325r |
AX0835r |
AX0840r |
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9 |
AX0915r |
AX0920r |
AX09225r |
AX0925r |
AX09275r |
AX0930r |
AX09325r |
AX0935r |
AX0940r |
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10 |
AX1015r |
AX1020r |
AX10225r |
AX1025r |
AX10275r |
AX1030r |
AX10325r |
AX1035r |
AX1040r |
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12 |
AX1215r |
AX1220r |
AX12225r |
AX1225r |
AX12275r |
AX1230r |
AX12325r |
AX1235r |
AX1240r |
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14 |
AX1415r |
AX1420r |
AX14225r |
AX1425r |
AX14275r |
AX1430r |
AX14325r |
AX1435r |
AX1440r |
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15 |
AX1515r |
AX1520r |
AX15225r |
AX1525r |
AX15275r |
AX1530r |
AX15325r |
AX1535r |
AX1540r |
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16 |
AX1615r |
AX1620r |
AX16225r |
AX1625r |
AX16275r |
AX1630r |
AX16325r |
AX1635r |
AX1640r |
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18 |
AX1815r |
AX1820r |
AX18225r |
AX1825r |
AX18275r |
AX1830r |
AX18325r |
AX1835r |
AX1840r |
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20 |
AX2015r |
AX2020r |
AX20225r |
AX2025r |
AX20275r |
AX2030r |
AX20325r |
AX2035r |
AX2040r |
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22 |
AX2215r |
AX2220r |
AX22225r |
AX2225r |
AX22275r |
AX2230r |
AX22325r |
AX2235r |
AX2240r |
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24 |
AX2415r |
AX2420r |
AX24225r |
AX2425r |
AX24275r |
AX2430r |
AX24325r |
AX2435r |
AX2440r |
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25 |
AX2515r |
AX2520r |
AX25225r |
AX2525r |
AX25275r |
AX2530r |
AX25325r |
AX2535r |
AX2540r |
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30 |
AX3015r |
AX3020r |
AX30225r |
AX3025r |
AX30275r |
AX3030r |
AX30325r |
AX3035r |
AX3040r |
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33 |
AX3315r |
AX3320r |
AX33225r |
AX3325r |
AX33275r |
AX3330r |
AX33325r |
AX3335r |
AX3340r |
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35 |
AX3515r |
AX3520r |
AX35225r |
AX3525r |
AX35275r |
AX3530r |
AX35325r |
AX3535r |
AX3540r |
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40 |
AX4015r |
AX4020r |
AX40225r |
AX4025r |
AX40275r |
AX4030r |
AX40325r |
AX4035r |
AX4040r |
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other lengths and diameters (e. g. 2.25 mm) on request
Compliance Data (In vitro compliance @ 37.5°C, tolerance ± 0.10 mm)
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Pressure atm / MPa |
Balloon Diameter (mm) |
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1.50 |
2.00 |
2.25 |
2.50 |
2.75 |
3.00 |
3.25 |
3.50 |
4.00 |
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2 / 0.2 |
1.21 |
1.71 |
1.96 |
2.21 |
2.46 |
2.71 |
2.96 |
3.21 |
3.71 |
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4 / 0.4 |
1.31 |
1.81 |
2.06 |
2.31 |
2.56 |
2.81 |
3.06 |
3.31 |
3.81 |
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6 / 0.6 |
1.41 |
1.91 |
2.16 |
2.41 |
2.66 |
2.91 |
3.16 |
3.41 |
3.91 |
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8 / 0.8 |
Nom. |
1.50 |
2.00 |
2.25 |
2.50 |
2.75 |
3.00 |
3.25 |
3.50 |
4.00 |
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10 / 1.0 |
1.54 |
2.06 |
2.31 |
2.56 |
2.81 |
3.06 |
3.31 |
3.56 |
4.08 |
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12 / 1.2 |
1.58 |
2.12 |
2.37 |
2.62 |
2.87 |
3.12 |
3.37 |
3.62 |
4.16 |
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14 / 1.4 |
1.62 |
2.18 |
2.43 |
2.68 |
2.93 |
3.18 |
3.43 |
3.68 |
4.24 |
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16
/ 1.6 |
RBP |
1.66 |
2.24 |
2.49 |
2.74 |
2.99 |
3.24 |
3.49 |
3.74* |
4.30* |
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18 / 1.8 |
1.69 |
2.27 |
2.52 |
2.78 |
3.03 |
3.29 |
3.55 |
3.80 |
4.36 |
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22 / 2.2 |
ABP |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
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24 / 2.4 |
-- |
ABP |
ABP |
-- |
-- |
-- |
ABP |
ABP |
ABP |
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26 / 2.6 |
-- |
-- |
-- |
ABP |
ABP |
ABP |
-- |
-- |
-- |
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Nom.:
Nominal Pressure
ABP: Average Burst Pressure
RBP: Rated Burst Pressure (do not exceed)
*14 atm for balloon diameter 3.50, 3.75 mm and balloon
length > 35 mm / for balloon diameter
4.00 mm and balloon length > 30 mm
Copyright
© alco GmbH, All rights reserved
http://www.alco-gmbh.de/