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.
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 |
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.
9100 Conroy Windermere Rd - Suite 200
Windermere, FL
34786 USA
Tel: 407.352.5200
2880 Main Street
Hopkinton, NY
12965 USA
Tel: 315.328.4491
45 Second Street West
Cornwall, Ontario
K6J1G3 CANADA
Tel: 613.936.2592