Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p33
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 33/696)
Character Range: 790715–809564

PTY LTD
AL037                                                           Ex-Press Glaucoma Filtration Device                                                                                  Miniature glaucoma shunt                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  50 microns; 200 microns                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $645.00

  01.05.02.02 - Non-Cannulated
     DEVICE TECHNOLOGIES AUSTRALIA PTY. LTD.
DE641                                                           ESNOPER Glaucoma Implant                                                                                             Glaucoma Drainage Implant                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 3.00mm x 1.40mm x 2.85mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $384.00

01.05.03 - Ab Interno Glaucoma Drainage Device
  01.05.03.01 - at Schlemm's canal
  smp
     EMERGO ASIA-PACIFIC PTY. LIMITED
ER501                                                           Hydrus Microstent                                                                                                    Intracanalicular scaffold, made from a biocompatible alloy, for the treatment of primary open angle glaucoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              8 mm in length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $1,264.00

  tda
     RQSOLUTIONS MEDICAL DEVICES DISTRIBUTION SUPPORT PTY LTD
RQ084                                                           Glaukos iStent inject W System                                                                                       An improved product to PLAC billing code RQ075 (product name iStent Inject) with a wider flange for better surgeon visualisation and stent confirmation. The improvement includes a delivery injection unit with 2 stents. Intended purpose per TGA submission is for implantation with or without cataract surgery and to reduce intraocular pressure in adult patients diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         One Size                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $1,444.00
RQ075                                                           iStent Inject System                                                                                                 The iStent Inject is a pre-loaded injection system which delivers two stents across the trabecular meshwork to provide a pathway for aqueous humor to flow from the anterior chamber. It is indicated for use in conjunction with cataract surgery for the reduction of IOP in subjects with mild to moderate open angle glaucoma currently treated with ocular hypotensive medication.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   One size                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $1,444.00
QQ325                                                           Glaukos iStent Infinite System                                                                                       The iStent infinite System consists of a single-use pre-loaded injector designed to deliver, with an unlimited insertion mechanism, three intraocular stents (Model G2-W) through a single incision into Schlemm's canal, creating a bypass through the trabecular meshwork to increase physiological aqueous outflow and reduce IOP. The stents used in the iStent infinite System are identical to those in iStent inject W (Billing code RQ084), which is designed to deliver two stents.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              One Size                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $1,444.00

                                                                                                                                                                                     As per the TGA submission and associated Instructions for Use, the iStent infinite is intended to reduce IOP in adult patients with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma, and can be performed with or without cataract surgery. It may also be implanted in patients who continue to have elevated IOP despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.

  01.05.03.02 - external to Schlemm's canal
     ABBVIE PTY LTD
QQ051                                                           XEN Glaucoma Treatment System                                                                                        The XEN Glaucoma Treatment System consists of an injector device that is preloaded with a XEN Gel Implant. The XEN Gel Implant creates a new subconjunctival outflow pathway to reduce intraocular pressure in patients with mild to advanced primary open-angle glaucoma where previous treatments have failed.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          XEN Gel Implant is 6mm long, 150µm outside diameter and 45µm inside diameter.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              $1,264.00

     RQSOLUTIONS MEDICAL DEVICES DISTRIBUTION SUPPORT PTY LTD