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Clinical Indications

Introduction

This page indicated the Clinical Implications across these treatments:

  • Selective Laser Trabeculoplasty
  • iTrack™ Canal-Based Glaucoma Surgery
  • Laser Floater Treatment
  • 2RT: Retinal Rejuvenation

Selective Laser Trabeculoplasty

Ellex is the manufacturer of the Tango Reflex and Tango for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma. Tango Reflex and Tango have been approved for the indication of Selective Laser Trabeculoplasty (SLT) whereby they may potentially improve patient IOP. Ellex does not accept any responsibility for use of the systems outside of this indication.

iTrack™ Canal-Based Glaucoma Surgery

Ellex is the manufacturer of the iTrack™ Canaloplasty microcatheter for the reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma. It has been approved for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal during the ABiC (ab-interno Canaloplasty) procedure. Ellex does not accept any responsibility for use of the iTrack Canaloplasty microcatheter outside of these indications.

iTrack™ has a CE Mark (Conformité Européenne) and US Food and Drug Administration (FDA) 510(k) # K080067 for the treatment of open-angle glaucoma.

Laser Floater Treatment

Ellex is the manufacturer of Reflex Technology for use in the treatment of symptomatic floater patients. It has been approved for the indication of Posterior Membranectomy (incl. Nd:YAG Laser Vitreolysis/Laser Floater Treatment) whereby it offers the potential to improve the patient’s perception of visual functionality. Ellex does not accept any responsibility for use of the system outside of these indications. The material presented herein may include the views or recommendations of third parties and does not necessarily reflect the views of Ellex Medical Pty Ltd.

Ultra Q Reflex™ has a CE Mark (Conformité Européenne) and US Food and Drug Administration (FDA) (510k) Market release for the treatment Posterior Membranectomy, Capsulotomy and Laser Iridotomy.

2RT: Retinal Rejuvenation

2RT has a CE Mark (Conformité Européene) for treatment in patients with early AMD where it can produce bilateral improvements in macular appearance and function.

2RThas a CE Mark (Conformité Européene) and US Food and Drug Administration (FDA) (510k) Market release for the treatment of Clinically Significant Macula Edema (CSME).

2RT is not approved for sale in the USA for the indication of early AMD.

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