Passeo-35 HP

Obraz
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Obraz
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Obraz
Passeo-35 HP Image
Passeo-35 HP High Pressure PTA Balloon
Obraz
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 Pressureatm5141414141414121212
            (NP)ø (mm)3.114.015.016.056.937.988.9610.0211.86
            Rated Burst Pressureatm5272727252322202018
            (RBP)ø (mm)3.424.415.466.567.458.59.6610.7812.41

            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