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

BALLOON/0.035"/OTW
INDICATED FOR ARTERIO-VENOUS DIALYSIS FISTULAE

Treats 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 anatomies
  • 96% success rate of opening arterio-venous dialysis fistulae3
  • Controlled compliance for excellent stability during inflation
  • Flexible and conformable to minimize straightening of the vessel

 

Product Details

Secure High-Pressure Fitting

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


Controlled Compliance for Excellent Stability

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


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.


Easy Re-Insertion

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


Passeo-35 HP

Minimal Vessel Straightening

Proprietary balloon technology designed for conformability and flexibility, delivering a vessel-friendly solution with an impressively high RBP of up to 27 atm, dilating resistant lesions in complex anatomies. Image shows a deployed balloon in silicone tubing5.


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 atm6 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 atm6 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


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1 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 Data on file at Creagh Medical.

6 1 atm = 1.013 bar; NP = normal pressure; RBP = rated burst pressure