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.
- 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
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
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.
Two radiopaque markers at balloon shoulders guarantee precise balloon positioning.
|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|
|Balloon Diameter x Length (mm)|
|Rated Burst Pressure||atm5||27||27||27||25||23||22||20||20||18|
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