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Atrioseptostomy

Z-6™

The Z-6™ leverages the same proven materials used in construction of the Z-5™. Product enhancements for the Z-6™ Atrioseptostomy catheter were made based on input from interventional pediatric cardiologists. Enhancements include a short distal tip for easier insertion through the septum and improved rewrapping allowing for easier removal into the introducer.

Unique Benefits

The Z-6™ features a non-compliant balloon that maintains its shape during pullback. The tip of the catheter is angled at 35 degrees to facilitate passage into the left atrium and is closer to the balloon than that of the Z-5™.  The Z-6™ catheter has a short distal tip for improved balloon rewrapping. The catheter body is radiopaque to facilitate reliable positioning of the catheter.  The smaller 9.5mm inflated balloon size makes atrioseptostomy easier to perform on neonates with a small left atrium. 9.5mm and 13.5mm balloon diameters are available on a 5F shaft. 

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 and Instructions for Use

Balloon Diameters (mm):  9.5 & 13.5
Balloon Lengths (cm):  0.95 & 1.35
Maximum Volume (CC): 1-2 
Introducer Size (FR):  6
Shaft Size (FR):  5
Indication:  Recommended for balloon atrioseptostomy
 

Z-6™ IFUs:
US: BIS Z-6 IFU
CANADA: RM0344-77B

Post Market Clinical Follow-up Form

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 6 5.0 50 0.021 1.0 Z695 Z6
13.5 1.35 6 5.0 50 0.021 2.0 Z6135 Z6

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.

 

NuMED for Children

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34786 USA
Tel: 407-352-5200

 

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Hopkinton, NY
12965 USA
Tel: 315-328-4491

 

NuMED Canada

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Cornwall, Ontario
K6J1G3 CANADA
Tel: 613-936-2592