Passeo-35-HP

Vascular Intervention // Peripheral
High Pressure PTA Balloon Catheter/0.035”/OTW

Passeo®-35 HP



     96% success rate opening arterio-venous dialysis fistulae

     Controlled compliance at high pressure

     Minimizing vessel straightening








96% success rate opening arterio-venous dialysis fistulae1


Arterio-venous Dialysis Fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialyses shunts. With a Rated Burst Pressure (RBP) of up to 27 atm, the highly flexible and conformable Passeo-35 HP reliably dilates these resistant lesions.

 

 


Controlled compliance at high pressure


Shape retention for precise dilatation.


 

 

 

 

 


Coaxial catheter shaft designed for flexibility, strength and rapid deflation


Coaxial catheter shaft design offering advanced flexibility at high strength while supporting rapid deflation. A faster approach to treat long lesions.



 

 

 

 

 


Minimizing vessel straightening


Proprietary balloon technology designed for conformability and flexibility. Delivering a vessel-friendly solution with impressively high RBP of up to 27 atm, dilating resistant lesions in complex anatomy.





Image showing deployed balloon in silicone tubing at 14 atm.3



 

 

 

 

Passeo-35 HP
 

Indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.*

 

 

Product Details

Technical Data

Passeo-35 HP Balloon Catheter
Catheter type
OTW
Recommended guide wire
0.035"
Tip
Soft, short, tapered
Balloon material
Nylon/pebax, controlled compliance
Balloon folding
3-fold (ø 3.0 - 9.0 mm); 5-fold (ø 10.0 - 12.0 mm)
Balloon markers
2 radiopaque markers
Sizes
ø 3.0 - 12.0 mm; L: 20 - 100 mm
Shaft
5.9 F, coaxial
Usable length
40 and 75 cm

Compliance Chart

Balloon Diameter x Length (mm)
Nominal Pressure atm5 14 14 14 14 14 14 12 12 12
(NP) ø (mm) 3.11 4.01 5.01 6.05 6.93 7.98 8.96 10.02 11.86
Rated Burst Pressure atm5 27 27 27 25 23 22 20 20 18
(RBP) ø (mm) 3.42 4.41 5.46 6.56 7.45 8.5 9.66 10.78 12.41

Ordering Information

3.0 (6F) - 399077 - - -
4.0 (6F) 399078 399079 - - -
5.0 (6F) 399080 399081 399082 - -
6.0 (6F) 399083 399084 399085 - 399086
7.0 (6F) 399087 399088 399089 - 399090
8.0 (6F) 399091 399092 399093 399094 -
9.0 (7F) - 399095 - - -
10.0 (7F) - 399096 - - -
12.0 (8F) - 399097 - - -
6.0 (6F) 399063
7.0 (6F) 399067
8.0 (6F) 399071

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1 BIOTRONIK data on file;

2 Prospective study of balloon inflation pressures and other technical aspects of hemodialysis access angioplasty. Trerotola SO, Kwak A, Clark TW, et al. J Vasc Interv Radiol. 2005 Dec; 16(12): 1613-8;

3 Data on file at Creagh Medical.

*Australia: Not TGA approved for use within the renal and common iliac arteries.