Indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.*
The coaxial catheter shaft design that creates a large balloon lumen facilitating rapid inflation and deflation.
The tri-fold balloon enables an enhanced crossability while minimizing slippage during inflation.
The balloon is fully coated with a hydrophilic coating when folded and only partly coated when inflated.
Different designs of the proximal and coaxial catheter shafts enable impressive pushability and high flexibility.
Impressive pushability due to catheter shaft design featuring a unique stiffening wire in the proximal shaft of the catheter, while enabling high flexibility due to a lower profile distal shaft in small, tortuous vessels.
| Balloon catheter | |
|---|---|
| Catheter type | OTW |
| Recommended guide wire | 0.014” |
| Tip | Optimized entry profile and colored |
| Balloon material | SCP (Semi-Crystalline Polymer), controlled compliance (4 - 6%) |
| Balloon folding | 3-fold |
| Balloon coating | Hydrophilic patchwork coating |
| Balloon markers | 2 swaged markers (zero profile) |
| Sizes | ø 1.5 - 4.0 mm; L: 20 - 220 mm |
| Distal shaft | 3.1F, hydrophilic coating, coaxial design; 150 mm length (ø 1.5 /2.0 x 20 - 100 mm); 75 mm length (ø 2.0 x 140 - 220 mm and ø 2.5 - 4.0 mm) |
| Proximal shaft | 3.9F, hydrophobic coating, coaxial design; stiffening wire |
| Usable length | 150 cm (ø 1.5 - 4.0 mm); 120 cm (ø 1.5 - 2.0 mm); 90 cm (ø 2.5 - 4.0 mm) |
| Balloon diameter x length (mm) | |||||||
|---|---|---|---|---|---|---|---|
| ø 1.5 x 20-70 | ø 2.0 x 40-220 | ø 2.5 x 40-220 | ø 3.0 x 40-220 | ø 3.5 x 40-140 | ø 4.0 x 40-140 | ||
|
Nominal Pressure [NP] |
atm* | 7 | 7 | 7 | 7 | 7 | 7 |
ø (mm) |
1.5 |
2.0 |
2.5 |
3.0 |
3.5 |
4.0 |
|
| Rated Burst Pressure [RBP] | atm* | 14 | 14 | 14 | 14 | 14 | 14 |
ø (mm) |
1.57 |
2.08 |
2.61 |
3.18 |
3.63 |
4.16 |
|
| Catheter cm Length (mm) |
Balloon ø (mm) |
Balloon Length (mm) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 20 | 40 | 70 | 100 | 140 | 180 | 220 | |||
|
4F Antegrade Approach |
120 | 1.5 | 380271a | 380277 | 380283 | - | - | - | - |
| 120 | 2 | - | 380278 | 380284 | 380290 | 380296 | 380302 | 380308 | |
| 90 | 2.5 | - | 380279 | 380285 | 380291 | 380297 | 380303 | 380309 | |
| 90 | 3 | - | 380280 | 380286 | 380292 | 380298 | 380304 | 380310 | |
| 90 | 3.5 | - | 380281a | 380287a | 380293a | 380299a | - | - | |
| 90 | 4 | - | 380282 | 380288 | 380294 | 380300 | - | - | |
| Catheter cm Length (mm) |
Balloon ø (mm) |
Balloon Length (mm) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 20 | 40 | 70 | 100 | 140 | 180 | 220 | |||
|
4F Crossover Approach |
150 | 1.5 | 380313a | 380319 | 380325 | - | - | - | - |
| 150 | 2 | - | 380320 | 380326 | 380332 | 380338 | 380344 | 380350 | |
| 150 | 2.5 | - | 380321 | 380327 | 380333 | 380339 | 380345 | 380351 | |
| 150 | 3 | - | 380322 | 380328 | 380334 | 380340 | 380346 | 380352 | |
| 150 | 3.5 | - | 380323a | 380329a | 380335a | 380341a | - | - | |
| 150 | 4 | - | 380324 | 380330 | 380336 | 380342 | - | - | |
| a8 weeks pre-order only | |||||||||
*Indication as per IFU.
1. BIOTRONIK data on file. Volume adjustment: A 3mm x 120mm balloon contains 17% less contrast media volume than a 3mm x 140mm balloon. The measured deflation time of a 3mm x 140mm balloon was adjusted by 17 % to make a direct competitive comparison; 2. BIOTRONIK Data on file.
Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.
