Heart Medical Europe B.V.

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Z-5™ Atrioseptostomy catheter

Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum. The SPT002 - 9.5mm is primarily for infants less than 2 kg.

The NuMED Z-5™ Atrioseptostomy catheter is engineered for maximum steering and tracking. The dual lumen shaft design provides pushability, coupled with exceptional pull strength. This new innovation in Atrioseptostomy catheter design is of potential importance in patients who are subject to a small left atrium and in small neonates with congenital heart disease requiring Atrioseptostomy.

  • General
  • Specifications
  • Catheter Characteristics

    The NuMED Z-5™ Atrioseptostomy catheter is engineered for maximum steering and tracking. The dual lumen shaft design provides pushability, coupled with exceptional pull strength. This new innovation in Atrioseptostomy catheter design is of potential importance in patients who are subject to a small left atrium and in small neonates with congenital heart disease requiring Atrioseptostomy.

    Radiopaque Catheter Body & Balloon Image Marker

    The NuMED Z-5™ Atrioseptostomy catheter body is Radiopaque to facilitate reliable positioning of the catheter. A platinum image marker band is placed under the balloon for clear identification under fluoroscopy.

    Micro-Thin Non-Compliant Balloon

    The NuMED Z-5™ Atrioseptostomy balloon is micro-thin for low deflated profile that maintains tip flexibility. The Inflation of the balloon is controlled by volume. (see volumetric chart-Instructions for Use)

    Reduced Balloon Size

    The reduced inflated balloon size should make Atrioseptostomy easier to perform on neonates with a small left atrium.

    Tip Angulation

    The tip of the catheter is angled at 35o to facilitate passage into the left atrium.

    Inner Lumen

    The NuMED Z-5™ Atrioseptostomy catheter has an inner lumen. The catheter end hole can accommodate a guidewire.

  • Product specifications

    Balloon
    Diameter
    (MM)
    Balloon
    Length
    (CM)
    Introducer
    Size
    (FR)
    Shaft
    Size
    (FR)
    Usable
    Length (CM)
    Guide
    Wire
    (Inches)
    Maximum
    Volume
    (CC)
    Catalog
    No.
    9.5 0.95 5 4 50 0.014 1 SPT002
    13.5 1.35 6 5 50 0.021 2 SPT003

    The devices listed have CE mark approval. Any customer or distributor outside of the EU will be subject to their individual country's regulations in regards to the importation and sale of these products.

    This publication could include technical or other inaccuracies or typographical errors. Changes are periodically added to the information herein; these changes will be incorporated in the new editions of the publication. NuMED Incorporated may make improvements and/or changes in the product(s) and/or the program(s) described in this publication at any time.