Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p116
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 116/696)
Character Range: 2706688–2734289

PerenniaFLEX Model 304.2 & 304.3                                                                                              Model 304 lead is a silicone insulated implantable patient lead, delivering the electrical signal from the Pulse Generator to the Vagus Nerve.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Lead Body                                                                                                                                                                                                                                                                                                                                                                         $3,069.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Diameter : 2mm (.08 in)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Insulation: Silicone
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Overall Length: 43cm

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Inner Diameter of Helix
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Model 304.20 ; 2mm (.08 in) inner diameter
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Model 304.30 ; 3mm (.12 in) inner diameter

04.08 - NEURO INTERVENTION
04.08.01 - Stent
     Culpan Medical Pty Ltd
CB012                                                                                           LVIS Intraluminal Support Device                                                                                                          Self-expanding intracranial vascular stent                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Diameters: 2.5, 3.0, 3.5, 4.0, 4.5, 5.5mm  Lengths: 8-67mm                                                                                                                                                                                                                                                                                                                        $6,769.00

     GETZ HEALTHCARE PTY LTD
ME209                                                                                           Leo+                                                                                                                                      Leo+ Stent                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        D 2.0mm L 12mm, 18mm, 25mm.                                                                                                                                                                                                                                                                                                                                                       $6,769.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            D 2.5mm L 12mm, 18mm, 25mm, 30mm, 35mm.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            D 3.0mm L 12mm, 18mm, 25mm, 35mm
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            D 3.5mm L 12mm, 18mm, 25mm, 30mm, 35mm, 50mm.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            D 4.5mm L 15mm, 20mm, 25mm, 30mm, 40mm, 50mm, 75mm.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            D 5.5mm L 25mm, 30mm, 35mm, 50mm, 60mm, 75mm.

     MEDTRONIC AUSTRALASIA PTY LTD
AS196                                                                                           Solitaire                                                                                                                                 Solitaire Neurovascular Remodelling Device is a self-expanding, fully retrievable device which can be delivered and deployed by a single operator.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Diameter: 3-6mm                                                                                                                                                                                                                                                                                                                                                                   $6,769.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Length: 15-40mm

     PENUMBRA NEURO AUSTRALIA PTY LTD
PN022                                                                                           ACCLINO Flex Plus Stent                                                                                                                   Acclino Flex Plus Stent is a self-expanding lasercut Nitinol stent for aneurysm neck bridging in case of stent assisted coiling procedures. It is intended for use with embolisation materials for the treatment of intracranial aneurysms. It provides an increased range and is suitable for vessel diameters from 1.5 to 7.0 mm. For an easy handling all sizes from 3.0  - 6.5 mm are deliverable through microcatheters with 0.0165 -   0.021  ID. This allows a sequential stent and coil placement without the changing of the microcatheter. The 8.0 mm diameter devices are deliverable through  microcatheters with 0.027 ID.                                                                                                                                                                                                                                                                                                                                                                                                                           Diameter: 3.0 - 8.0mm  Length: 15 - 60 mm                                                                                                                                                                                                                                                                                                                                         $6,769.00
PN023                                                                                           ACCERO Stent                                                                                                                              ACCERO Stent is a highly visible,braided self-expanding stent with BlueXide® surface technology.The self-expanding braided stent is characterised by an excellent opening behaviour,  superior wall apposition and a very smooth surface. It is intended for use with embolization materials in the treatment of intracranial aneurysms. Accero's full range of sizes can be delivered through a small 0.0170" microcatheter and can be resheathed up to 95%.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Stent Diameter (mm): 2.5, 3.0, 3.5,4.0, 4.5           Stent Length (mm): 10, 15, 20, 25                                                                                                                                                                                                                                                                                           $6,769.00

     STRYKER AUSTRALIA PTY LTD
HW470                                                                                           Wingspan Stent System                                                                                                                     Wingspan Self Expanding Nitonol Stent and delivery catheter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Stent diameters: 2.5mm to 4.5mm; Stent lengths: 9.0mm to 20.0mm                                                                                                                                                                                                                                                                                                                   $6,769.00
HW567                                                                                           Neuroform ATLAS Stent System                                                                                                              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