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Endovascular

Paclitaxel coated peripheral angioplasty balloon catheter PAK OTW/RX

Medical use
Peripheral angioplasty
Basic UDI-DI
5901297PAKFK

Paclitaxel coated peripheral angioplasty balloon catheters are catheters of „over the wire” (OTW) type.

Distal part of the catheter consists of two channels. External channel is used for inflating the balloon, and internal channel is the guide wire. Catheter has two markers enabling precise determination of balloon position in the vessel. 


The balloon is covered with a coating POLIGRADE® and  drug paclitaxel an amount to 2,5 µg/mm2, which is eluting during balloon inflation. Paclitaxel is a white crystalline powder with chemical formula C47H51NO14 and molecular mass 853.9 g/mol. This is highly lipophilic substance, insoluble in water, which melts at the temperature of 213 – 215°C. Paclitaxel belongs to alkaloids group from taxanes group. It is cytostatic and it inhibits the cell cycle in G2/M phase. It shows antimitotic action, which is combined with microtubules depolimerization inhibition, preventing from proper distribution of chromatydes and which leads to mitosis process disturbance. By inhibiting division of cells and their migration, paclitaxel allows for limiting restenosis phenomenon. Paclitaxel selectively inhibits smooth myocytes proliferation, while the endothelium cells show higher resistance to its action. In addition, paclitaxel restricts inflammatory conditions in walls of the arteries after balloon angioplasty. 

Intended purpose:

PAK, paclitaxel-coated peripheral angioplasty balloon catheter, is intended for dilating of de novo or restenotic atherosclerotic lesions in iliac and femoropopliteal arteries with reference vessel diameters between 1.25 mm and 8 mm.

    Technical data overview

    WITH DELIVERY SYSTEM OVER THE WIRE (OTW)

    Balloon material  nylon 
    Balloon coating  POLIGRADE® coating with paclitaxel (2,5 μg/mm2)
    Balloon diameters  3.00-8.00 mm 
    Balloon lengths  20-250 mm 
    Nominal pressure (for balloon diameters 3.00 mm) 10 atm
    Nominal pressure (for balloon diameters 4.00-8.00 mm) 6 atm
    Deflated time   short
    Pushability and trackability  very good
    Delivery system  Over The Wire (OTW)
    Delivery system lengths 80, 100, 110, 120, 135 cm

     

    WITH DELIVERY SYSTEM RAPID EXCHANGE (RX)

    Balloon material  nylon
    Balloon coating  POLIGRADE® coating with paclitaxel (2.5 μg/mm2)
    Balloon diameters  1.25-7.00 mm 
    Balloon lengths  10-40 mm 
    Nominal pressure  8 atm
    Deflated time short 
    Pushability and trackability  excellent 
    Compatible guidewire   max 0.014”
    Delivery system  Rapid Exchange (RX)
    Delivery system lengths 140 cm

    Available versions

    WITH DELIVERY SYSTEM OVER THE WIRE (OTW)

    Reference: Nominal
    balloon diameter
    [mm]    		 Nominal
    balloon length
    [mm]    		 Use with
    guidewire
    [inch]    		 Use with
    introducer
    [F]    		 Catheter
    length
    [cm]
    C E
    PAKOTW3xCE110 3 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 0.018 4 110
    PAKOTW3xCE110 3 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 0.025 5 110
    PAKOTW3xCE110 3 100, 150, 200 0.025 6 110
    PAKOTW4xCE110 4 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70 0.018 4 110
    PAKOTW4xCE110 4 75, 80, 85, 90, 95, 100 0.025 6 110
    PAKOTW4xCE110 4 150, 200, 250 0.025 7 110
    PAKOTW4xCE110 4 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 0.035 6 110
    PAKOTW4xCE110 4 100, 150, 200, 250 0.035 7 110
    PAKOTW5xCE110 5 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 0.018 5 110
    PAKOTW5xCE110 5 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 0.025 6 110
    PAKOTW5xCE110 5 70, 75, 80, 85, 90, 95, 100 0.025 7 110
    PAKOTW5xCE110 5 150, 200, 250 0.025 8 110
    PAKOTW5xCE110 5 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 0.035 6 110
    PAKOTW5xCE110 5 70, 75, 80, 85, 90, 95 0.035 7 110
    PAKOTW5xCE110 5 100, 150, 200, 250 0.035 8 110
    PAKOTW6xCE110 6 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 0.018 5 110
    PAKOTW6xCE110 6 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 0.025 6 110
    PAKOTW6xCE110 6 70, 75, 80, 85, 90, 95 0.025 7 110
    PAKOTW6xCE110 6 100, 150, 200, 250 0.025 8 110
    PAKOTW6xCE110 6 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 0.035 6 110
    PAKOTW6xCE110 6 70, 75, 80, 85, 90, 95 0.035 7 110
    PAKOTW6xCE110 6 100, 150, 200, 250 0.035 8 110
    PAKOTW7xCE110 7 20, 25, 30, 35, 40, 45 0.035 7 110
    PAKOTW7xCE110 7 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250 0.035 8 110
    PAKOTW8xCE110 8 20, 25, 30, 35, 40, 45 0.035 7 110
    PAKOTW8xCE110 8 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 0.035 8 110

     

    WITH DELIVERY SYSTEM RAPID EXCHANGE (RX)

    Reference: Nominal
    balloon diameter
    [mm]    		 Minimum Guiding
    Catheter I.D. [ich]    		 Nominal
    balloon length
    [mm]
    G
    PAKRX1.25xG140 1.25 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX1.50xG140 1,5 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX1.75xG140 1.75 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX2.00xG140 2 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX2.25xG140 2.25 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX2.50xG140 2.5 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX2.75xG140 2.75 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX3.00xG140 3 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX3.25xG140 3.25 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX3.50xG140 3.5 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX3.75xG140 3.75 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX4.00xG140 4 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX4.50xG140 4.5 0.066 10, 15, 20, 25, 30, 35, 40
    PAKRX5.00xG140 5 0.071 10, 15, 20, 25, 30, 35, 40
    PAKRX6.00xG140 6 0.071 10, 15, 20, 25, 30, 35, 40
    PAKRX7.00xG140 7 0.088 10, 15, 20, 25, 30, 35, 40