The FREEWAY™ 014 Paclitaxel-eluting PTA balloon dilatation catheter is an over-the-wire (OTW) catheter which is specially designed for peripheral interventions in infra-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 forpost-dilatation after stent implantation in the peripheral vascular system.
FREEWAY™ 014 – DRUG-ELUTING PTA BALLOON TECHNOLOGY
| Design | Coaxial design – OTW |
| Shaft Diameter | distal 3.1 F / medial 3.8 F / proximal 3.8 F |
| Balloon diameter | 2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm |
| Balloon length | 40 – 150 mm |
| Usable catheter length (tip to strain relief) | 120 cm and 150 cm |
| Guide wire diameter | 0.014″ (0.36 mm) |
| Shaft coating | Hydrophilic |
| Balloon coating | Paclitaxel (3μg/mm²) within a shellac matrix (1:1 ratio) |
| Balloon material | PA, Polyamid/Nylon |
| Balloon folding | 2-folding for 2.0 mm 3-folding for 2.5 – 4.0 mm |
| Balloon characteristic | Semi-compliant |
| Recommended introducer sheath | 4 F |
| Nominal pressure | 6 atm |
| Rated burst pressure | Diameter 2.0 – 2.5 mm: 16 atm Diameter 3.0 – 4.0 mm: 14 atm |
| Packaging unit | 1 unit |
FREEWAY™ 014
Pressurization
| Inflation (atm/bar) | Pressure (kPa) |
|---|---|
| 4 | 400 |
| 6* | 600* |
| 8 | 800 |
| 10 | 1000 |
| 12 | 1200 |
| 14** | 1400** |
| 16** | 1600** |
| 18 | 1800 |
| 20 | 2000 |
Balloon Diameter (mm)
| 2.00 | 2.50 | 3.00 | 3.50 | 4.00 |
|---|---|---|---|---|
| 1.88 | 2.37 | 2.79 | 3.27 | 3.82 |
| 2.00* | 2.50* | 3.00* | 3.50* | 4.00* |
| 2.09 | 2.60 | 3.17 | 3.72 | 4.12 |
| 2.16 | 2.70 | 3.29 | 3.87 | 4.19 |
| 2.22 | 2.77 | 3.39 | 4.00 | 4.27 |
| 2.27 | 2.83 | 3.46** | 4.10** | 4.35** |
| 2.33** | 2.89** | 3.54 | 4.18 | 4.42 |
| 2.42 | 2.94 | 3.61 | 4.26 | 4.50 |
| 2.53 | 3.00 |
* Nominal pressure
** Rated burst pressure
FREEWAY™ 014
Balloon Size / Shaft Length
| Diameter (mm) | Length (mm) | Order Information | L / XL – 120 / 150 cm |
|---|---|---|---|
| 2.00 | 40 | 114-2040 | L / XL |
| 2.00 | 80 | 114-2080 | L / XL |
| 2.00 | 120 | 114-20120 | L / XL |
| 2.00 | 150 | 114-20150 | L / XL |
| 2.50 | 40 | 114-2540 | L / XL |
| 2.50 | 80 | 114-2580 | L / XL |
| 2.50 | 120 | 114-25120 | L / XL |
| 2.50 | 150 | 114-25150 | L / XL |
| 3.00 | 40 | 114-3040 | L / XL |
| 3.00 | 80 | 114-3080 | L / XL |
| 3.00 | 120 | 114-30120 | L / XL |
| 3.00 | 150 | 114-30150 | L / XL |
| 3.50 | 40 | 114-3540 | L / XL |
| 3.50 | 80 | 144-3580 | L / XL |
| 3.50 | 120 | 114-35120 | L / XL |
| 3.50 | 150 | 114-35150 | L / XL |
| 4.00 | 40 | 114-4040 | L / XL |
| 4.00 | 80 | 114-4080 | L / XL |