FREEWAY™ 035

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FREEWAY™ 035

The FREEWAY™ 035 Paclitaxel-eluting PTA balloon dilatation catheter is an over-the-wire (OTW) catheter which is specially designed for peripheral interventions in femoral-popliteal lesions. It is indicated for widening stenosis of de novo and restenotic lesions in the iliac, femoral, iliac-femoral, popliteal, infra-popliteal and renal arteries. This balloon is also used for post-dilatation after stent implantation in the peripheral vascular system.

FREEWAY™ 035 – DRUG-ELUTING PTA BALLOON TECHNOLOGY

Design Bilumen design – catheter
Balloon diameter 4.0 / 5.0 / 6.0 / 7.0 and 8.0 mm
Balloon length 20 – 230 mm
Usable catheter length (tip to strain relief) 80 cm and 135 cm
Guide wire diameter 0.035″ (0.91 mm)
Shaft coating Hydrophilic
Balloon coating Paclitaxel (3μg/mm²) within a shellac matrix (1:1 ratio)
Balloon material PA, Polyamid/Nylon
Balloon folding 4-folding for 4 mm and 5 mm
5-folding for 6 – 8 mm
Balloon characteristic Semi-compliant
Recommended introducer sheath 5 F for 4.0 – 6.0 mm Diameter
6 F for 6.0 and length ≥ 100 mm
6 F for 7.0 and 8.0 mm Diameter
Recommended balloon inflation time 120 sec
Nominal Pressure 6 atm
Rated burst pressure Balloon length 20 / 40 / 60 mm Diameter 4 – 6 mm: 16 atm
Balloon length 20 / 40 / 60 mm Diameter 7 – 8 mm: 14 atm
Balloon length 80 / 100 / 120 / 150 mm Diameter 4 mm: 16 atm
Balloon length 190 / 230 mm Diameter 4 mm: 14 atm
Balloon length 80 / 100 / 120 / 150 mm Diameter 5 – 6 mm: 14 atm
Balloon length 190 / 230 mm Diameter 5-6 mm: 12 atm
Balloon length 80 / 100 / 120 / 150 mm Diameter 7 – 8 mm: 12 atm
Balloon length 190 / 230 mm Diameter 7 mm: 10 atm
Packaging unit 1 unit

 

FREEWAY™ 035

Pressurization

Inflation (atm/bar) Pressure (kPa)
4 400
6 * 600 *
8 800
10 **** 1000 ****
11 1100
12 **** *** 1200 **** ***
13 1300
14 **** *** ** 1400 **** *** **
15 1500
16 *** ** 1600 *** **
17 1700
18 1800

Balloon Diameter (mm)

4.00 5.00 6.00 7.00 8.00
3.78 4.80 5.68 6.67 7.45
4.00* 5.00* 6.00* 7.00* 8.00*
4.15 5.15 6.16 7.19 8.31
4.28 5.26 6.30 7.33**** 8.53
4.33 5.31 6.37 7.41 8.64
4.40 5.37**** 6.44**** 7.48*** 8.77***
4.46 5.43 6.52 7.55 8.89
4.53**** 5.49*** 6.59*** 7.63** 9.00**
4.60 5.58 6.67 7.70 9.12
4.67** *** 5.64** 6.79** 7.78 9.25
4.75 5.72 6.84
4.83 5.80

* Nominal pressure
** Rated Burst Pressure (RBP) for balloon length 20 – 60 mm
*** Rated Burst Pressure (RBP) for balloon length 80 – 150 mm
**** Rated Burst Pressure (RBP) for balloon length 190 – 230 mm

FREEWAY™ 035

Balloon Size / Shaft Length

Diameter (mm) Length (mm) Order
Information
S/L
80/135 cm
4.0 20 335-4020 S / L
4.0 40 335-4040 S / L
4.0 60 335-4060 S / L
4.0 80 335-4080 S / L
4.0 100 335-40100 S / L
4.0 120 335-40120 S / L
4.0 150 335-40150 S / L
4.0 190 335-40190 S / L
4.0 230 335-40230 S / L
5.0 20 335-5020 S / L
5.0 40 335-5040 S / L
5.0 60 335-5060 S / L
5.0 80 335-5080 S / L
5.0 100 335-50100 S / L
5.0 120 335-50120 S / L
5.0 150 335-50150 S / L
5.0 190 335-50190 S / L
5.0 230 335-50230 S / L
6.0 20 335-6020 S / L
6.0 40 335-6040 S / L
6.0 60 335-6060 S / L

Balloon Size / Shaft Length

Diameter (mm) Length (mm) Order
Information
S/L
80/135 cm
6.0 80 335-6080 S / L
6.0 100 335-60100 S / L
6.0 120 335-60120 S / L
6.0 150 335-60150 S / L
6.0 190 335-60190 S / L
6.0 230 335-60230 S / L
7.0 20 335-7020 S / L
7.0 40 335-7040 S / L
7.0 60 335-7060 S / L
7.0 80 335-7080 S / L
7.0 100 335-70100 S / L
7.0 120 335-70120 S / L
7.0 150 335-70150 S / L
7.0 190 335-70190 S / L
7.0 230 335-70230 S / L
8.0 20 335-8020 S / L
8.0 40 335-8040 S / L
8.0 60 335-8060 S / L
8.0 80 335-8080 S / L
8.0 100 335-80100 S / L