Low profile, wide range of sizes
Passeo-35 balloon catheter features a low profile design for 5F and 6F sheath compatibility, a wide range of balloon diameters (3.0-10.0 mm) and lengths of up to 200 mm.
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Passeo®-35
Low profile, puncture resistant balloon with enhanced crossability
Indicated to dilate stenosis in the renal, iliac1, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.*
Product Highlights
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Low profile and wide range of sizes
Features a low profile design for 5F and 6F sheath compatibility, a wide range of balloon diameters (3.0-10.0 mm) and lengths of up to 200 mm.
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Puncture resistant
A robust balloon that provides effective dilation for more calcified lesions.
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Enhanced crossability
The penta-fold balloon is fully coated when folded and only partly coated when inflated. This enables enhanced crossability while minimizing slippage during inflation of most calcified lesions.
Low profile, wide range of sizes
Puncture resistant
Puncture resistant
A robust balloon that provides effective dilation for more calcified lesions.
Enhanced crossability
Patchwork coating for enhanced crossability
The penta-fold balloon is fully coated when folded and only partly coated when inflated. This enables enhanced crossability while minimizing slippage during inflation of most calcified lesions.
Technical Data
| Balloon catheter | |
|---|---|
| Catheter type | OTW |
| Recommended guide wire | 0.035” |
| Tip | Soft, short, tapered, colored |
| Balloon material | SCP (Semi-Crystalline Polymer), controlled compliance |
| Balloon folding | 5-fold |
| Balloon coating | Hydrophobic patchwork coating |
| Balloon markers | 2 swaged markers |
| Sizes | ø 3.0 - 10.0 mm; L: 20 - 200 mm |
| Shaft | 5F, hydrophobic coating, dual-lumen |
| Usable length | 80, 90 and 130 cm |
| Guide wire lumen | Hydrophobic coating |
Compliance Chart
| Balloon diameter x length (mm) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ø 3.0 x 20-40 |
ø 3.0 x 60-200 |
ø 4.0 x 20-40 |
ø 4.0 x 60-200 |
ø 5.0 x 20-100 |
ø 5.0 x 120-200 |
ø 6.0 x 20-100 |
ø 6.0 x 120-200 |
ø 7.0 x 20-200 |
ø 7.0 x 120-200 |
ø 8.0 20-200 |
ø 9.0 x 20-80 |
ø 10.0 x 20-40a |
ø 10.0 x 20-80 |
||
| Nominal Pressure (NP) |
atm* ø (mm) |
7 3.0 |
7 3.00 |
7 4.0 |
7 4.00 |
7 5.0 |
7 5.0 |
7 6.0 |
7 6.0 |
7 7.0 |
7 7.0 |
7 8.0 |
7 9.0 |
7 10.0 |
7 10.0 |
| Rated Burst Pressure (RBP) |
atm* ø (mm) |
20 3.5 |
20 3.20 |
20 4.5 |
18 4.32 |
16 5.7 |
16 5.3 |
16 6.7 |
16 6.4 |
14 7.7 |
14 7.3 |
14 8.7 |
12 9.4 |
12 10.5 |
11 10.3 |
| aUsable length: 80 cm; *1 atm = 1.013 bar | |||||||||||||||
Ordering Information
| Balloon ø (mm) |
Catheter length 80 cm Balloon length (mm) |
|||||
|---|---|---|---|---|---|---|
| 20 | 40 | 60 | 80 | 100 | ||
| 5F | 3.0 | 359545 | 359547 | - | - | - |
| 4.0 | 359546 | 359548 | - | - | - | |
| 5.0 | 357282 | 357288 | 357294 | 357298 | 357302 | |
| 6.0 | 357283 | 357289 | 357295 | 357299 | 357303 | |
| 7.0 | 357284 | 357290 | 357296 | 357300 | 357304 | |
| 6F | 8.0 | 357285 | 357291 | 357297 | 357301 | 357305 |
| 9.0 | 357286 | 357292 | - | - | - | |
| 10.0 | 357287 | 357293 | - | - | - | |
| b8 weeks pre-order only | ||||||
| Balloon ø (mm) |
Catheter length 90 cm Balloon length (mm) |
|||||||
|---|---|---|---|---|---|---|---|---|
| 60 | 80 | 100 | 120 | 150 | 170 | 200 | ||
| 5F | 3.0 | 383231 | 383235 | 383239 | 383243 | 389775 | 389776b | 387162 |
| 4.0 | 383232 | 383236 | 383240 | 383244 | 383248 | 383252b | 383256 | |
| 5.0 | - | - | - | 383245 | 383249 | 383253b | 383257 | |
| 6.0 | - | - | - | 383246 | 383250 | 383254b | 383258 | |
| 7.0 | - | - | - | 383247 | 383251 | 383255b | 383259 | |
| 6F | 8.0 | - | - | - | - | - | - | - |
| 9.0 | 383233 | 383237 | - | - | - | - | - | |
| 10.0 | 383234 | 383238 | - | - | - | - | - | |
| b8 weeks pre-order only | ||||||||
| Balloon ø (mm) |
Catheter length 130 cm Balloon length (mm) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 20 | 40 | 60 | 80 | 100 | 120 | 150 | 170 | 200 | ||
| 5F | 3.0 | 359549 | 359551 | 383264 | 383268 | 383272 | 383276 | 389777 | 389778 | 387163 |
| 4.0 | 359550 | 359552 | 383265 | 383269 | 383273 | 383277 | 383281 | 383285 | 383289 | |
| 5.0 | 357306 | 357310 | 357314 | 357318 | 357322 | 383278 | 383282 | 383286 | 383290 | |
| 6.0 | 357307 | 357311 | 357315 | 357319 | 357323 | 383279 | 383283 | 383287 | 383291 | |
| 7.0 | 357308 | 357312 | 357316 | 357320 | 357324 | 383280 | 383284 | 383288 | 383292 | |
| 6F | 8.0 | 357309 | 357313 | 357317 | 357321 | 357325 | - | - | - | - |
| 9.0 | 383260 | 383262 | 383266 | 383270 | - | - | - | - | - | |
| 10.0 | 383261 | 383263 | 383267 | 383271 | - | - | - | - | - | |
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References
*Indication as per IFU.
1. Australia: not TGA approved for use within the renal and common illiac arteries.
Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies.