In eyes with primary open-angle glaucoma, identifying where blockage or resistance occurs within the conventional outflow pathway can be hard.
Targeting the trabecular meshwork alone, or isolating a single point, may not be enough to lower IOP.
75% of Surgeons want to address the conventional outflow pathway first1
Between 50-75% of resistance may be in the Trabecular Meshwork2,3,4
Up to 50% of resistance may be in Schlemm’s canal and the distal collector channels2,3,4
ONE MIGS device
TWO implant-free procedures
THREE points of resistance
intelligently designed device.
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OMNI™ Surgical System
Indications and Safety Information
Indications for use
The OMNI™ Surgical System is indicated for the catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.
1. Do not use the OMNI in any situations where the angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.
2. Do not use the OMNI in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.
1. Do not use in cases where there is insufficient visibility to properly see the angle. The following conditions may prohibit sufficient visualization of the angle required for safe and successful cannula placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit gonioscopic view of the angle and intended cannula entry location.
2. Perform gonioscopy prior to taking a patient to surgery to exclude congenital anomalies of the angle, anterior segment dysgeneses, peripheral anterior synechiae (PAS), rubeosis, and any other angle abnormalities that could lead to improper placement of the cannula and microcatheter and pose a hazard.
3. Maintain direct microscopic or gonioscopic visualization of the cannula tip and microcatheter tip at all times during the procedure to facilitate advancement and to avoid inadvertently damaging intraocular structures, kinking the microcatheter or unintended tearing of trabecular meshwork.
Potential adverse events
Adverse events that may be reasonably associated with the use of the OMNI™ System in the eye include but are not limited to the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation including toxic anterior segment syndrome (TASS), endophthalmitis or other ocular infection, aqueous misdirection, Descemet’s membrane tear or detachment, intracorneal hematoma, choroidal effusion, suprachoroidal hemorrhage, corneal decompensation, corneal injury, corneal edema or opacification, unintended trabeculotomy, cyclodialysis cleft, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, cataract formation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal flap tears, secondary surgical intervention, including but not limited to glaucoma surgery, and vitreous hemorrhage.
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