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.
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.
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
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