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
Two radiopaque markers at balloon shoulders enable precise balloon positioning.
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 guidewire | 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.
1. Successful dilatation defined as full balloon dilation during treatment - BIOTRONIK data on file (PME report, 2013); 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.
Conquest is a registered trademark of Bard Peripheral Vascular, Inc.
Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies.
