Heart Medical Europe B.V.

Unique flexible coil occluder for the closure of Ventricular Septal Defects (VSD). Perimembranous (aneurysmatic) and muscular VSDs can be treated. In all 350 cases (1, 2) no permanent heart (AV) block was reported.

  • General
  • Specifications
  • Patented coil design with polyester fibres

    The coil design with securely attached polyester fibres results in a rapid, effective and safe VSD occlusion.

    Outstanding adaptation properties

    Nit-Occlud® Lê VSD adapts perfectly to the anatomy of perimembranous VSDs (especially in those with aneurysmatic formation) as well as muscular VSDs.

    Safety for the patient’s benefit

    Due to its flexible design, no permanent AV-Blocks occurred in more than 350 (1, 2) reported cases.

    Broad range of different sizes

    Nit-Occlud® Lê VSD is available in diameters 8, 10, 12, 14 and 16 mm (largest distal winding), making the implant suit­able for closing VSDs of various shapes and sizes.

    Small Delivery Sheaths

    Nit-Occlud® Lê VSD can be deployed through small introducer sheaths of 6F and 7F.

    Trials and registries

    1 "International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion" (clinicatrials.gov identifier NCT00390702).

  • Product specifications

    Permanent coil for the closure of perimembranous and muscular ventricular septal defects (VSD)

    REF Dital Coil
    diameter (D)
    Proximal Coil
    diameter (P)
    Recommended
    long sheath
    Implantation
    catheter length
    149086 8 mm 6 mm 6 F 105 cm
    149106 10 mm 6 mm 6 F 105 cm
    149126 12 mm 6 mm 6 F 105 cm
    149148 14 mm 8 mm 7 F 105 cm
    149168 16 mm 8 mm 7 F 105 cm