product

Passeo®-35 HP High Pressure PTA Balloon

Passeo®-35 HP high pressure PTA balloon indicated for use in percutaneous transluminal angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.*

*Australia: Not TGA approved for use within the renal and common iliac arteries.

Manufacturer Info

Biotronik BIOTRONIK AG
Ackerstrasse 6
8180 Bülach - Switzerland

Why to use it

• 96% success rate opening arteriovenous dialysis fistulae1: Arteriovenous dialysis fistulae commonly require high pressure dilatations2 due to the fibrotic-like morphology of these hemodialysis 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.

• Minimized 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.

• 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.

 

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.
Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies.

Characteristics

Balloon Catheter Technical Data
Catheter TypeOTW
Recommended Guidewire0.035"
TipSoft, short, tapered
Balloon MaterialNylon/Pebax, controlled compliance
Balloon Folding3-fold (ø 3.0 - 9.0 mm); 5-fold (ø 10.0 - 12.0 mm)
Balloon Markers2 radiopaque markers
Sizesø 3.0 - 12.0 mm; L: 20 - 100 mm
Shaft5.9F, coaxial
Usable Length40 cm and 75 cm