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Passeo®-35 HP

Unique high-pressure PTA Balloon to dilate resistant lesions in complex anatomy

Passeo-35 HP is a unique high pressure PTA Balloon to dilate most resistant lesions in complex anatomy.1 It is 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.*

Category

Vascular Intervention Peripheral PVI Balloon Catheters

Product Highlights

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96% success rate opening arterio-venous dialysis fistulae¹

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Controlled compliance at high pressure

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Minimizing vessel straightening

96% success rate opening arterio-venous dialysis fistulae¹

With a RBP* of up to 27 atm, the highly flexible and conformable Passeo-35 HP reliably dilates resistant lesions

Arterio-venous Dialysis Fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialyses shunts. 



*RBP = Rated Burst Pressure

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Controlled compliance at high pressure

Shape retention for precise dilatation

The balloon keeps its conical shape even at high pressure. There is no deformation of the shoulders which could result in an inaccurate marker to the balloon position.

Minimizing vessel straightening

Flexible and conformable to minimize 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.

Product Overview

Passeo-35 HP

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Technical Data

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 5.9F, coaxial
Usable length 40 cm and 75 cm

 

Compliance Chart

  Balloon diameter x length (mm)
    ø 3.0 x

40
ø 4.0 x

20-40
ø 5.0 x

20-60
ø 6.0 x

20-100
ø 7.0 x

20-100
ø 8.0 x

20-80
ø 9.0 x

40
ø 10.0 x

40
ø 12.0 x

40
Nominal Pressure

(NP)
atm**

ø (mm)
14

3.11
14

4.01
14

5.01
14

6.05
14

6.93
14

7.98
12

8.96
12

10.02
12

11.86
Rated Burst Pressure

(RBP)
atm**

ø (mm)
27

3.42
27

4.41
27

5.46
25

6.56
23

7.45
22

8.50
20

9.66
20

10.78
18

12.41
**1 atm = 1.013 bar

Ordering Information

 

  Balloon
ø (mm)
Catheter length 75 cm
Balloon length (mm)
      Catheter length 40 cm
Balloon length (mm)
 
    20 40 60 80 100 40
6F 3.0 - 399077 - - - -
4.0 399078 399079 - - - -
5.0 399080 399081 399082 - - -
6.0 399083 399084 399085 - 399086 399063
7.0 399087 399088 399089 - 399090 399067
8.0 399091 399092 399093 399094 - 399071
7F 9.0 - 399095 - - - -
10.0 - 399096 - - - -
8F 12.0 - 399097 - - - -

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References

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

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.

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