MINIject - iSTAR Medical

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 implant targeting the supraciliary space, which is shown to deliver safe, meaningful and sustained control of intraocular pressure (IOP).

“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.

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 properties¹
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.

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

Instructions for use (IFU)

Current IFU

MINIject (FG1004Px)

Version 3, 2024-09-27

English / German / French / Italian / Dutch / Spanish

Version 3, 2024-09-27

English / Portuguese / Finnish / Norwegian / Swedish

IFU Archive

MINIject (FG1004)

Version 13, 2022-09-16

English / German / Spanish / French / Italian / Dutch

Version 13, 2022-09-16

Swedish / Norwegian / Finnish / Portuguese

MINIject (FG1004)

Version 12, 2022-08-18

English / German / Spanish / French / Italian / Dutch

Version 12, 2022-08-18

Swedish / Norwegian

Version 11, 2021-10-04

English / German / Spanish / French / Italian / Dutch

Version 10, 2021-07-14

English / German

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, Norway, Iceland, Switzerland and Australia.

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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