Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p117
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 117/696)
Character Range: 2734034–2749486

The Neuroform Atlas (Atlas) Stent System is intended to be used for stent assisted embolization for intracranial aneurysm therapy. The purpose of the stent is to retain the occlusive devices within the aneurysm. Occlusive devices can be delivered prior to stent placement or after stent placement. The Atlas Stent System consists of a self-expanding, sterile, nitinol stent preloaded over a delivery wire inside an introducer sheath.  The sheath and delivery wire are used to transfer the stent into a 0.0165 to 0.017 inch internal diameter microcatheter.  After transferring the stent, the sheath is removed from the proximal end of the delivery wire. The delivery wire is then used to advance the stent to the distal end of the microcatheter. The microcatheter and stent system are repositioned as a unit to ensure the stent is located across the aneurysm. The stent is deployed by stabilizing the delivery wire and withdrawing the microcatheter. The Neuroform Atlas stent cannot be repositioned or captured once deployed.  Stent Diameter (mm): 3.0, 4.0, 4.5                                                                                                                                                                                                                                                                                                                                                $6,769.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Stent Length (mm): 15, 21, 24, 30

04.08.02 - Coils
     Culpan Medical Pty Ltd
CB010                                                                                           Hydrocoils                                                                                                                                Framing and filling coils with Hydrogel.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Diam: 1-24mm  Length: 1-50cm                                                                                                                                                                                                                                                                                                                                                      $1,043.00
CB011                                                                                           Microplex Coils                                                                                                                           Framing and filling coils                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Diam: 1-24mm                                                                                                                                                                                                                                                                                                                                                                      $1,043.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Length: 1-68cm

     GETZ HEALTHCARE PTY LTD
ME226                                                                                           Optima Coil System                                                                                                                        Implantable embolization Coil comprised of platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Various sizes as attached.                                                                                                                                                                                                                                                                                                                                                        $1,043.00

     HYDRIX SERVICES PTY LTD
JZ001                                                                                           Wallaby Avenir Coil System                                                                                                                Platinum alloy coils attached to an implant delivery pusher which delivers the coil to the treatment site.  The pusher has a platinum iridium marker band to visualise coil position within a standard microcatheter which also has a radiopaque marker.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Diameter: 1mm - 25mm  Length: 1cm - 60cm                                                                                                                                                                                                                                                                                                                                          $1,043.00

     MEDTRONIC AUSTRALASIA PTY LTD
AS193                                                                                           Axium Detachable Coil System                                                                                                              Platinum alloy coils (including coils enlaced with PGLA filaments and Nylon Fibers)  attached to a composite implant delivery pusher with a radiopaque positioning marker.  The proximal end of the pusher is loaded into the Actuator which detaches the coil.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Diameter: 1.5 - 25mm; Length: 1 - 50cm                                                                                                                                                                                                                                                                                                                                            $1,043.00
MI240                                                                                           Axium Prime Detachable Coil - Extra Soft                                                                                                  Platinum alloy embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and hand-held Instant Detacher, which when activated, mechanically detaches the coil from the delivery pusher tip.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          3D Shape: diameter 1 to 3.5 mm;  length 2 to 10 cm; Volume 1.34 to 6.70 mm3                                                                                                                                                                                                                                                                                                       $1,043.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Helical Shape: diameter 1 to 3 mm;  length 1 to 10 cm; Volume 0.67  to 6.70 mm3

     PENUMBRA NEURO AUSTRALIA PTY LTD
PN003                                                                                           Penumbra Coil System