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 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