Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p434
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 434/696)
Character Range: 15080065–15095763

AMPLATZER Vascular Plug II is a self-expandable, multi-lobed cylindraical device made from a nitinol wire mesh.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3mm-22mm Diameter, 6mm-18mm Plug Length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            $1,895.00

  Microcatheter
     DIVERSE DEVICES PTY LTD
DL006                                                                                      IMPEDE Embolization Plug                                                                                                   The IMPEDE Embolization Plug is a pushable embolization device comprised of a self-expanding porous Shape Memory Polymer (SMP) Plug and a proximal platinum/iridium markerband or distal pre-shaped helical Anchor Coil comprised of nitinol and platinum, and a proximal platinum marker band..  The device is supplied pre-loaded in an Introducer with the SMP Plug in a crimped state. It is designed to be delivered to the target vessel using a guidewire through a standard catheter/sheath. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the SMP Plug will self-expand to embolize the target vessel.  The IMPEDE Embolization Plug System is packaged as a single unit and is provided sterile, non-pyrogenic, and is intended for single use only.                                                                                                                                                                                                                                                         5mm, 6 mm, 7mm, 8 mm, 10mm, 12 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $1,895.00

     MEDTRONIC AUSTRALASIA PTY LTD
MI185                                                                                      MVP Microvascular Plug System                                                                                              MVP Microvascular Plug can be delivered through a microcatheter to enable rapid occlusion.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Unconstrained device diameter (mm): 5.3, 6.5, 9.2, & 13.0                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $1,895.00

10.08.05 - Liquid
     GETZ HEALTHCARE PTY LTD
ME229                                                                                      SQUID LIQUID EMBOLIC AGENT                                                                                                 SQUID is a non-adhesive, liquid embolic agent consisting of an ethylene vinyl alcohol (EVOH ) copolymer dissolved in DMSO (dimethyl sulfoxide), and suspended micronized tantalum powder to provide contrast for visualisation under fluoroscopy.  The SQUID Liquid Embolic System consists of a vial of SQUID, a vial of DMSO, two SQUID delivery syringes, one DMSO delivery syringe, two syringe adapters and 8 stickers to identify the vials of SQUID.  A SQUID-compatible delivery micro-catheter, the use of which is indicated for the neurovascular system (Sonic, Balt catheters) is used to access the embolization site.  The adapter is an interface between the SQUID delivery syringe and the delivery catheter.                                                                                                                                                                                                                                                                                                                                            12, 12LD, 18, 18LD formulations                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $2,076.00

     MEDTRONIC AUSTRALASIA PTY LTD
MI208                                                                                      Onyx 6ml Kit                                                                                                               DMSO Liquid Embolic Material                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               6ml Kit                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            $7,265.00
AS190                                                                                      Onyx                                                                                                                       DSMO/Liquid Embolic Material                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               18, 20, 34 (formulations)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $2,076.00

  ids (integral delivery system)
     MEDTRONIC AUSTRALASIA PTY LTD
AS191                                                                                      Onyx System                                                                                                                DSMO Liquid Embolic Material                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               500 Formulation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $4,468.00

  10.08.05.02 - Cyanoacrylate
     DIVERSE DEVICES PTY LTD
DL004                                                                                      VenaBlock Venous Closure System                                                                                            VenaBlock is an n-Butyy Cyanoacrylate-polymer structure which was modified by adding a monomer synthesized by the producing company. It is a ready for use, blue colored, transparent liquid. The product exhibits a polymerization effect with embolization. When in contact with living tissue and in humid environments, it rapidly polymerises  by forming a thin, flexible membrane with high tension resistance that adheres firmly to the tissues.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  One size                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           $713.00

     MEDTRONIC AUSTRALASIA PTY LTD
MI285                                                                                      VenaSeal™ Closure System