MINIject GLAUCOMA DEVICE

 

MINIject® is a minimally-invasive glaucoma surgery (MIGS) device for patients with open-angle glaucoma developed by iSTAR Medical SA, Wavre, Belgium.

MINIject® is a MIGS implant targeting the supraciliary space.

MINIject® is designed to 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. The device is inserted into the nasal quadrant of the eye through a 2 mm clear corneal incision. The unique flexible design conforms to the shape of the eye.

The MINIject is 5 mm in length with an oblong cross-sectional design measuring 1.1×0.6 mm. A green ring positioned at 0.5 mm from the tip of the device allows for accurate positioning in the anterior chamber.

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

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

Another advantage of the device is that it is implanted far away from the cornea (only 0.5mm in the anterior chamber).

CLINICAL DATA:

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

• 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
• Favorable endothelial cell density safety at two years

In a study by Philippe Denis, Christoph Hirneiß, Georges M Durr, et al, the study cohort had mean baseline IOP of 23.2±2.9 mmHg using a mean of 2.0±1.1 glaucoma medications. The primary endpoint at 6 months was met, with a signification reduction in IOP of 9.0 mmHg.

The mean reduction in IOP 24 months after surgery was 40.7% compared with baseline, to a mean diurnal IOP of 13.8 ±3.5 mmHg at 24 months.

The most frequent adverse events were anterior chamber reaction (8/26 patients, 30.8%), visual acuity reduced (8/ 26, 30.8%), VF defect (7/26, 26.9%), IOP elevation (5/26, 19.2%) and lenticular opacities (5/26, 19.2%).