Z-5™
Atrioseptostomy
Z-5™
The Z-5™ Atrioseptostomy catheter was developed in collaboration with Dr Ziyad Hijazi and was first approved and introduced in 1996. With over 25 years of proven safety and clinical experience, the Z-5™ is trusted by interventional pediatric cardiologists throughout the world. The dual lumen shaft design provides pushability, coupled with exceptional pull strength. The Z-5™is available in 9.5mm and 13.5mm diameters.
Unique Benefits
The Z-5™ features a micro-thin non-compliant balloon for a low deflated profile that maintains its flexibility. The balloon inflation is controlled by volume. The tip of the catheter is angled at 35 degrees to facilitate passage into the left atrium. The Z-5™ catheter has a dual lumen, with an end hole that can accommodate a guidewire. The catheter body is radiopaque to facilitate reliable positioning of the catheter. The reduced 9.5mm inflated balloon size makes atrioseptostomy easier to perform on neonates with a small left atrium.
The catheter body is Polymeric, DEHP-free, and not made with natural rubber latex. The balloon is a thermoplastic elastomer (non-compliant), DEHP-free, and not made with natural rubber latex.
Specifications, IFUs, and Forms
Balloon Diameters (mm): 9.5 & 13.5
Balloon Lengths (cm): 0.95 & 1.35
Maximum Volume (CC): 1-2
Introducer Size (FR): 5-6
Indication: Recommended for balloon atrioseptostomy
Z-5™ IFUs:
US: IFU-210B
CANADA: RM0344-05L
INTERNATIONAL: RM0344-05L
Post Market Surveillance Form
Post Market Surveillance Form NCI
| Balloon Diameter (mm) | Balloon Length (cm) | Introducer (FR) | Shaft Size (FR) | Usable Length (cm) | Guide Wire (inches) | Maximum Volume (cc) | Catalog Number | Product |
|---|---|---|---|---|---|---|---|---|
| 9.5 | 0.95 | 5 | 4.0 | 50 | 0.014 | 1 | SPT002 | Z5 ATRIO |
| 13.5 | 1.35 | 6 | 5.0 | 50 | 0.021 | 2 | SPT003 | Z5 ATRIO |
Disclaimer
All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.
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