MINIject - Micro-Invasive Glaucoma Surgery Device (MIGS)
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).
INTENDED USE
MINIject® is intended to be used to reduce intraocular pressure (IOP) by channelling aqueous humour out of the anterior chamber to the supraciliary space, thus enhancing physiological uveoscleral outflow.
INDICATIONS FOR USE
MINIject® is indicated in adult patients diagnosed with open angle glaucoma.
CONTRAINDICATIONS
MINIject™ is contraindicated if one or more of the following conditions exist:
- eyes with angle closure glaucoma;
- eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle;
- patients with known intolerance or hypersensitivity to silicone.
WARNINGS
The MINIject™ implant is intended for long-term use. The physician should monitor the patient postoperatively for proper maintenance of IOP as performance may change over time. If IOP is not adequately maintained, the physician should consider appropriate additional therapy to maintain the target IOP.
PRECAUTIONS
- The MINIject Delivery System is single-use only and cannot be reused or reloaded.
- The implant should not be removed after placement unless there a positive benefit/risk as assessed by the surgeon.
- The safety and effectiveness of the use of more than a single MINIject™ implant in a single eye has not been established.
DEVICE MATERIAL INFORMATION
The MINIject™ implant is composed of a porous medical-grade silicone it is 5.0 mm long with an oblong cross section of 1.1 x 0.6 mm. The parts of the Delivery System that enter the eye during surgery are made of medical-grade polyimide and medical-grade stainless steel. These Delivery System parts have only transient contact with eye tissues.
MRI INFORMATION
The MINIject implant is magnetic resonance (MR) Safe: the implant is constructed of silicone, a non-conducting, non-metallic, non-magnetic material that poses no known hazards in all magnetic resonance imaging environments.
For more information, please request the latest Summary of Safety and Clinical Performance on our contact page.
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 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
- Approximately half of patients drop-free
- Low rate of complications
- No needling or bleb-management required
- Favourable endothelial cell density safety at two years
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®’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
- 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