PTCA DEB

Sirolimus eluting PTCA catheter

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The first Sirolimus eluting PTCA catheter with ultra low crossing profile and high pressure capability Of course Made In Germany
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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

Type of catheter design Double lumen PTCA catheter
Drug Product A conformal coating of a polymer carrier loaded with 1,4 µg Sirolimus/mm2 applied to the Balloon
Catheter design details Rapid exchange, 140 cm working length, 25 cm from tip
Balloon type semi-compliant
Balloon folding Three-folding
Proximal shaft 1.95 F
Distal shaft 2.70F
Radio markers Femoral and brachial markers
Standard lengths 8/9/10/12/14/15/16/18/20/22/24/25/30/33/35/40 mm, other length on demand
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
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
Nominal inflation pressure 8 atm (0.8 MPa)
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
Flexibility Excellent
Average crossing profile 0.017" (0.43 mm)
Min. guiding catheter I.D. 0.058" (1.47 mm)
Max. guide wire O.D. 0.014" (0.36 mm)
Storage Store in a dry place below 40°C, Keep away from light
Sterilization Ethylene oxide gas (ETO)

Order-Number

Balloon
length(mm)
Balloon diameter (mm)
1.50 2.00 2.25 2.50 2.75 3.00 3.25 3.50 4.00
8 AX0815r AX0820r AX08225r AX0825r AX08275r AX0830r AX08325r AX0835r AX0840r
9 AX0915r AX0920r AX09225r AX0925r AX09275r AX0930r AX09325r AX0935r AX0940r
10 AX1015r AX1020r AX10225r AX1025r AX10275r AX1030r AX10325r AX1035r AX1040r
12 AX1215r AX1220r AX12225r AX1225r AX12275r AX1230r AX12325r AX1235r AX1240r
14 AX1415r AX1420r AX14225r AX1425r AX14275r AX1430r AX14325r AX1435r AX1440r
15 AX1515r AX1520r AX15225r AX1525r AX15275r AX1530r AX15325r AX1535r AX1540r
16 AX1615r AX1620r AX16225r AX1625r AX16275r AX1630r AX16325r AX1635r AX1640r
18 AX1815r AX1820r AX18225r AX1825r AX18275r AX1830r AX18325r AX1835r AX1840r
20 AX2015r AX2020r AX20225r AX2025r AX20275r AX2030r AX20325r AX2035r AX2040r
22 AX2215r AX2220r AX22225r AX2225r AX22275r AX2230r AX22325r AX2235r AX2240r
24 AX2415r AX2420r AX24225r AX2425r AX24275r AX2430r AX24325r AX2435r AX2440r
25 AX2515r AX2520r AX25225r AX2525r AX25275r AX2530r AX25325r AX2535r AX2540r
30 AX3015r AX3020r AX30225r AX3025r AX30275r AX3030r AX30325r AX3035r AX3040r
33 AX3315r AX3320r AX33225r AX3325r AX33275r AX3330r AX33325r AX3335r AX3340r
35 AX3515r AX3520r AX35225r AX3525r AX35275r AX3530r AX35325r AX3535r AX3540r
40 AX4015r AX4020r AX40225r AX4025r AX40275r AX4030r AX40325r AX4035r AX4040r
other lengths and diameters (e. g. 2.25 mm) on request

Compliance Data (In vitro compliance @ 37.5°C, tolerance ± 0.10 mm)



Pressure
atm / MPa Balloon Diameter (mm)
Balloon diameter (mm)
1.50 2.00 2.25 2.50 2.75 3.00 3.25 3.50 4.00
2 / 0.2 1.21 1.71 1.96 2.21 2.46 2.71 2.96 3.21 3.71
4 / 0.4 1.31 1.81 1.96 2.06 2.31 2.56 3.06 3.31 3.81
6 / 0.6 1.41 1.91 2.16 2.41 2.66 2.91 3.16 3.41 3.91
8 /0.8 Nom. 1.50 2.00 2.25 2.50 2.75 3.00 3.25 3.50 4.00
10 / 1.0 1.54 2.06 2.31 2.56 2.81 3.06 3.31 3.56 4.08
12 / 1.2 1.58 2.12 2.37 2.62 2.87 3.12 3.37 3.62 4.16
14 / 1.4 1.62 2.18 2.43 2.68 2.93 3.18 3.43 3.68 4.24
16 /1.6 RBP 1.66 2.24 2.49 2.74 2.99 3.24 3.49 3.74* 4.30*
18 / 1.8 1.69 2.27 2.52 2.78 3.03 3.29 3.55 3.80 4.36
22 / 2.2 ABP -- -- -- -- -- -- -- --
24 / 2.4 -- ABP ABP -- -- -- ABP ABP ABP
26 / 2.6 -- -- -- ABP ABP ABP -- -- --

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

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