* Cardiovascular products are only available to purchase in Latin America and the Carribean. Not available in US markets.
The FREEWAY™ 014 and 035 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™ 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 |
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