Passeo-35 HP

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Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Image
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Image
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Image
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon

Passeo®-35 HP

HIGH PRESSURE PTA BALLOON

Indicated for arterio-venous dialysis fistulae. Treatment of femoral, iliac1and renal1 arteries. Arterio-venous dialysis fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialyses shunts.


KEY FACTS
  • Up to 27 atm to dilate resistant lesions in complex anatomy
  • 96% success rate opening arterio-venous dialysis fistulae3
  • Controlled compliance for excellent stability during inflation
  • Flexible and conformable minimizing vessel straightening

 

Product Details

Secure High-Pressure Fitting

Extraordinary one-piece molded hub delivering secure high-pressure fitting designed to support actual burst pressure up to 45 atm.4


Easy Re-Insertion

Balloon re-wrap tool, pre-loaded on shaft, facilitating easy re-insertion.


Passeo-35 HP

Controlled Compliance for Excellent Stability

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


Passeo-35 HP

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.


Precise Positioning

Two radiopaque markers at balloon shoulders guarantee precise balloon positioning.


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


Contact

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Country/Region

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

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 BIOTRONIK data on file (PME report, 2013).

4 Refer to compliance chart for RBP.

5 1 atm = 1.013 bar

Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies.