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.*
Arterio-venous Dialysis Fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialyses shunts.
*RBP = Rated Burst Pressure
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.
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.
| 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 |
| 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 | ||||||||||
| 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 | - | - | - | - |
*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.
