The FREEWAY™ 035 AV Paclitaxel-eluting PTA balloon dilatation catheter is an over-the-wire (OTW) catheter which is specially designed for peripheral arteriovenous (AV) interventions in dialysis patients. It is indicated for widening stenosis of de novo and restenotic AV fistulas and shunt graft lesions to reduce re-interventions and to preserve future treatment options.
FREEWAY™ AV – HIGH PRESSURE DRUG-ELUTING PTA BALLOON TECHNOLOGY
| Balloon Name | FREEWAY™ 035 |
| Design | Bilumen design – over the wire catheter |
| Balloon diameter | 4.0 / 5.0 / 6.0 / 7.0 / 8.0 mm |
| Balloon length | 20, 40 and 60 mm |
| Usable catheter length (tip to strain relief) | 40 cm |
| Guide wire diameter | 0.035″ (0.89 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 mm and 7 mm |
| Balloon characteristic | Semi-compliant |
| Recommended introducer sheath | 6 F for 4.0 to 6.0 mm Diameter 7 F for 7.0 to 8.0mm Diameter |
| Recommended balloon inflation time | 120 sec |
| Nominal pressure | 12 atm |
| Rated burst pressure | Balloon length 20/40 mm Diameter 4 –7 mm: 20 atm Balloon length 60 mm Diameter 4 –7 mm: 18 atm Balloon length 20/40/60 mm Diameter 8 mm: 18 atm |
| Packaging unit | 1 unit |
FREEWAY™ AV Shunt
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 *** ** |
| 19 | 1900 |
| 20 ** | 2000 ** |
Balloon Diameter (mm)
| 4.00 | 5.00 | 6.00 | 7.00 | 8.00 |
|---|---|---|---|---|
| 3.56 | 4.44 | 5.32 | 6.15 | 7.09 |
| 3.68 | 4.61 | 5.52 | 6.45 | 7.36 |
| 3.80 | 4.75 | 5.69 | 6.66 | 7.60 |
| 3.91 | 4.89 | 5.86 | 6.85 | 7.80 |
| 3.96 | 4.95 | 5.94 | 6.93 | 7.91 |
| 4.00* | 5.00* | 6.00* | 7.00* | 8.00* |
| 4.04 | 5.05 | 6.08 | 7.09 | 8.13 |
| 4.07 | 5.10 | 6.14 | 7.15 | 8.21 |
| 4.10 | 5.14 | 6.20 | 7.21 | 8.30 |
| 4.13 | 5.18 | 6.26 | 7.28 | 8.39 |
| 4.15 | 5.22 | 6.33 | 7.35 | 8.50 |
| 4.18*** | 5.26*** | 6.40*** | 7.42*** | 8.62** *** |
| 4.21 | 5.30 | 6.47 | 7.49 | 8.71 |
| 4.24** | 5.35** | 6.54** | 7.57** | 8.81 |
* Nominal Pressure
** Rated Burst Pressure (RBP) for balloon length 20–40 mm
*** Rated Burst Pressure (RBP) for balloon length 60 mm and 20–60 mm for balloon diameter 8.00mm
FREEWAY™ AV Shunt
Balloon Size / Shaft Length
| Diameter (mm) | Length (mm) | Order Information | AV (Shunt) 40 cm |
|---|---|---|---|
| 4.0 | 20 | 335-4020 | AV |
| 4.0 | 40 | 335-4040 | AV |
| 4.0 | 60 | 335-4060 | AV |
| 5.0 | 20 | 335-5020 | AV |
| 5.0 | 40 | 335-5040 | AV |
| 5.0 | 60 | 335-5060 | AV |
| 6.0 | 20 | 335-6020 | AV |
| 6.0 | 40 | 335-6040 | AV |
| 6.0 | 60 | 335-6060 | AV |
| 7.0 | 20 | 335-7020 | AV |
| 7.0 | 40 | 335-7040 | AV |
| 7.0 | 60 | 335-7060 | AV |
| 8.0 | 20 | 335-8020 | AV |
| 8.0 | 40 | 335-8040 | AV |
| 8.0 | 60 | 335-8060 | AV |