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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.*

Category

Vascular Intervention Peripheral PVI Balloon Catheters

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

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.

Image

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 383254 383258
7.0 - - - 383247 383251 383255 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.