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 |