Patient Safety Information

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.