Passeo®-35 HP
High Pressure PTA Balloon/0.035"/OTW
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 arterio-venous dialysis fistulae. Arterio-venous Dialysis Fistulae commonly require high pressure dilatation1 due to fibrotic-like morphology of these hemodialysis shunts.
Key Facts
- Up to 27 atm to dilate resistant lesions in complex anatomy
- 96% success rate dilating arterio-venous dialysis fistulae2
- Coaxial catheter shaft designed for flexibility and rapid balloon deflation
- Flexible and conformable to minimize vessel straightening
Product Details
Secure High-Pressure Fitting
One-piece molded hub strong enough to withstand up to 45 atm.3 (Warning: never inflate balloon above recommened RBP)
Coaxial catheter shaft design
Coaxial catheter shaft is designed to offer advanced flexibility at high strength while supporting rapid balloon deflation. The coaxial design allows for a large lumen to enable contrast media solution to flow more quickly to and from the balloon.
Easy Re-Insertion
Balloon re-wrap tool, pre-loaded on shaft facilitating re-insertion through sheath during the procedure.
Minimizing 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 tubing.4
Precise Positioning
Two radiopaque markers at balloon shoulders enable 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
1 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.
2 Successful dilatation defined as full balloon dilation during treatment, BIOTRONIK data on file (PME report, 2013).
3 Refer to compliance chart for RBP.
4 Data on file at Creagh Medical.
5 1 atm = 1.013 bar; NP = normal pressure; RBP = rated burst pressure