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Passeo-35 HP craking

Passeo-35 HP craking

Passeo-35 HP craking

Product catalog summary
Product Overview: Passeo-35 HP is a high-pressure PTA balloon catheter designed for use in arterio-venous dialysis fistulae and the treatment of femoral, iliac, and renal arteries. It is part of BIOTRONIK's vascular intervention solutions.
Specifications: The catheter is available in sizes ranging from 3.0 mm to 12.0 mm in diameter and 20 mm to 100 mm in length. It features a coaxial shaft design, a soft, short, tapered tip, and is compatible with a 0.035" guide wire. The balloon material is made of Nylon/Pebax with controlled compliance, and it includes two radiopaque markers for precise positioning.
Performance: The Passeo-35 HP can withstand pressures up to 27 atm, making it suitable for dilating resistant lesions in complex anatomies. It boasts a 96% success rate in opening arterio-venous dialysis fistulae. The balloon's design minimizes vessel straightening and offers excellent stability during inflation.
Compliance and Pressure Ratings: The nominal pressure (NP) is 14 atm for most sizes, with a rated burst pressure (RBP) of up to 27 atm for smaller diameters. Larger diameters have slightly lower RBP values.
Design Features: The catheter includes a balloon re-wrap tool for easy re-insertion, a secure high-pressure fitting, and a coaxial catheter shaft for advanced flexibility and rapid deflation. The one-piece molded hub supports burst pressures up to 45 atm.
Regulatory Note: In Australia, the Passeo-35 HP is not TGA approved for use within the renal and common iliac arteries.
Ordering Information: The product is available in various configurations, with specific ordering codes for different balloon sizes and catheter lengths. For purchasing, contact local sales representatives.
Manufacturer and Distributor: The Passeo-35 HP is manufactured by Creagh Medical in Ireland and distributed by BIOTRONIK AG in Switzerland.
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Catalog excerpts

Passeo-35 HP craking-1

Vascular Intervention // Peripheral High Pressure PTA Balloon/0.035"/OTW Indicated for arterio-venous dialysis fistulae   reatment of femoral, iliac1 and renal1 arteries T   to 27 atm to dilate resistant lesions in complex anatomy Up   % success rate opening arterio-venous dialysis fistulae2 96   Controlled compliance for excellent stability during inflation   Flexible and conformable minimizing vessel straightening Australia: Not TGA approved for use within the renal and common iliac arteries BIOTRONIK data on file (PME report, 2013)

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Passeo-35 HP craking-2

Passeo-35 HP Cracking the most difficult challenge A unique High Pressure PTA Balloon to dilate most resistant lesions in complex anatomy Arterio-venous Dialysis Fistulae commonly require high pressure dilatations3 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: ■ 96 % success rate of opening Arterio-venous Dialysis Fistulae.2 High pressure balloon in atm* (NP/RBP) Balloon Catheter length 40, 75 cm ‘ 1 atm = 1.013 bar; NP = Normal Pressure;...

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Passeo-35 HP craking-3

Technical Data Balloon catheter Catheter type OTW Recommended guide wire 0.035" Tip Soft, short, tapered Balloon material Nylon/Pebax, controlled compliance Balloon markers 2 radiopaque markers Catheter length 40 cm Balloon length [mm) 40 Ordering Information Balloon Catheter length 75 cm 0 [mm) Balloon length [mm) 20 40 60 80 100 Solutions portfolio, including: ■ Introducer Sheath: Fortress ■ Balloons: Passeo-35 ■ Stents: Dynamic, Astron, Pulsar-35 Manufacturer: Creagh Medical IDA Business Park Ballinasloe Co. Galway Ireland For ordering please contact your...

 Open the catalog to page 3

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.