MINIject

MINIject® is iSTAR Medical’s innovative minimally-invasive glaucoma surgery (MIGS) device for patients with open-angle glaucoma.

 

MINIject® is currently the only commercially available MIGS device targeting the supraciliary space, which is shown to deliver safe, meaningful and sustained control of intraocular pressure (IOP).

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“Over the next five years, MIGS will drive the glaucoma device market” Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021

Designed to be a leading MIGS device

 

MINIject® is designed to significantly reduce IOP by enhancing natural outflow from the anterior chamber to the supraciliary space. Implantation is predictable in a single-step procedure using a deployment wheel.

 

 

 

 

 

 

MINIject and STAR material
STAR material

STAR Material

MINIject®’s distinctive, soft and flexible porous structure delivers multiple benefits:

  • iSTAR Medical’s proprietary STAR® material exhibits outstanding anti-fibrotic and anti-inflammatory properties 1
  • Porous implant enables a natural flow of aqueous humor, helping reduce fibrosis, minimise scarring and increase durability 1
  • Conforms to the eye’s anatomy and bio-integrates with surrounding tissue to sustain long-term drainage efficacy 1,2
MINIject implanted in suprachoroidal space

Swift and intuitive access through the supraciliary space

  • A safe, minimally-invasive, ab-interno procedure 3
  • Spares the conjunctiva and avoids bleb formation
  • Implanted far away from the cornea (only 0.5mm in the anterior chamber) 3
  • Minimises post-operative patient management and recovery time 3

Key benefits

 

MINIject® is currently the only commercially available MIGS device that enhances natural flow in the supraciliary space with bio-integration, for safe, meaningful and sustained control of IOP.

 

 

MINIject on a finger

Clinical Data

Clinical data of MINIject® in standalone trials at two-year follow-up has shown: 3

  • 35-40% mean IOP reduction after two years
  • Meaningful IOP reduction to <15mmHg in most patients
  • Approximately half of patients drop-free
  • Low rate of complications
  • No needling or bleb-management required
  • Favourable endothelial cell density safety at two years
MINIject delivery system

Instructions for use (IFU)

Current IFU

MINIject (5425033254131) – version 11, 2021-10-04

IFU Archive

MINIject (5425033252939) – version 10, 2021-07-14

 

PATIENT SAFETY INFORMATION

Please contact us at [email protected] if you require further information.

 

MINIject® is only available for sale in the European Union, the UK and Switzerland.

MINIject® safety and efficacy results are currently sustained out to 3 years, as presented by Dr Ike Ahmed at WGC 2021.

1 Grierson I, Minckler D, Rippy MK et al. “A novel suprachoroidal microinvasive glaucoma implant: in vivo biocompatibility and biointegration.” BMC biomed eng 2, 10 (2020).

2 Ultrasound Biomicroscopy (UBM) images on file

3 Data on file and presented by CEO Michel Vanbrabant at Ophthalmology Innovation Summits (OIS) in 2021. Denis P, Hirneiß C, Durr GM, et al. “Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial”. Br J Ophthalmol 2020;0:1–6

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