Vascular Intervention // Peripheral
High Pressure PTA Balloon Catheter/0.035”/OTW
Passeo®-35 HP
96% success rate opening arterio-venous dialysis fistulae
Controlled compliance at high pressure
Minimizing vessel straightening
96% success rate opening arterio-venous dialysis fistulae1
Arterio-venous Dialysis Fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialyses shunts. With a Rated Burst Pressure (RBP) of up to 27 atm, the highly flexible and conformable Passeo-35 HP reliably dilates these resistant lesions.
Controlled compliance at high pressure
Shape retention for precise dilatation.
Coaxial catheter shaft designed for flexibility, strength and rapid deflation
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.
Image showing deployed balloon in silicone tubing at 14 atm.3
Passeo-35 HPIndicated 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.*
Product Details
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
| 3.0 (6F) | - | 399077 | - | - | - | |||||||||
| 4.0 (6F) | 399078 | 399079 | - | - | - | |||||||||
| 5.0 (6F) | 399080 | 399081 | 399082 | - | - | |||||||||
| 6.0 (6F) | 399083 | 399084 | 399085 | - | 399086 | |||||||||
| 7.0 (6F) | 399087 | 399088 | 399089 | - | 399090 | |||||||||
| 8.0 (6F) | 399091 | 399092 | 399093 | 399094 | - | |||||||||
| 9.0 (7F) | - | 399095 | - | - | - | |||||||||
| 10.0 (7F) | - | 399096 | - | - | - | |||||||||
| 12.0 (8F) | - | 399097 | - | - | - | |||||||||
| 6.0 (6F) | 399063 | |||||||||||||
| 7.0 (6F) | 399067 | |||||||||||||
| 8.0 (6F) | 399071 | |||||||||||||
Contact
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.
*Australia: Not TGA approved for use within the renal and common iliac arteries.