Intelligent design
meets the
proven pathway.

Intelligent design
meets the
proven pathway.

One

MIGS device.

Two

implant-free procedures.

Three

points of resistance.

For

more patients.

Targeting the three points of resistance in the conventional outflow pathway

Only OMNI™ Surgical System lets you target the three points of resistance – trabecular meshwork, Schlemm’s canal and distal collector channels – with one sophisticated device.

Why is targeting the conventional outflow pathway so important?

1

It contributes around 80% of outflow in a normal eye1

2

Episcleral venous pressure physiologically creates a barrier that may avoid hypotony

3

75% of surgeons want to restore natural outflow via the conventional outflow pathway first2

  1. Francis B, Akil H, Bert B. Ab interno Schlemm’s Canal Surgery. Dev Ophthalmol. 2017;59:127-146.
  2. Ianchulev T, Ahmed IK, Stamper RL, Chang DF, Samuelson TW, Lindstrom R. Innovative Alternatives in the Surgical Management of Glaucoma with Cataract Surgery. Expert Review of Ophthalmology. 2017; 12:5, 403-419, DOI: 10.1080/17469899.2017.1362335.

Two procedures in one intelligently designed device

The OMNI Surgical System is a manually operated device indicated for the delivery of small amounts of viscoelastic fluid during ophthalmic surgery through a custom microcatheter. It is also indicated for the cutting of trabecular meshwork when a trabeculotomy is indicated.

Transluminal Viscoelastic Delivery

With its unique implant-free approach, the OMNI™ Surgical System lets you access Schlemm’s canal with the microcatheter through a single clear corneal incision. Intelligently engineered with an internal reservoir delivering a controlled amount of viscoelastic fluid.

Titratable Trabeculotomy

To address the trabecular meshwork as a point of resistance within the conventional outflow pathway, the OMNI™ Surgical System lets you perform a titratable trabeculotomy customized to meet your surgical plan.

Intelligently engineered, implant free, disposable system

Intelligently engineered, implant free, disposable system

Play Video

One

MIGS device.

Two

implant-free procedures.

Three

points of resistance.

For

more patients.

Reimbursement Facts

Two distinct Category 1 CPT Codes associated with procedures that can be performed with the OMNI™ Surgical System
• 66174 – Transluminal canal dilation
• 65820 – Ab interno trabeculotomy

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Important Safety Information

Indications for use

The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or HealonGV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

Disclaimer

The OMNI™ Surgical System is cleared (indicated) by FDA for the uses set forth above. While the OMNI system is not specifically cleared for transluminal canal dilation, there is support for its use (and the use of one of its parent devices, the VISCO360) in transluminal canal dilation in the literature and medical textbooks1,2,3,4, and ab interno trabeculotomy, for which it is FDA-cleared, is referred to as a MIGS procedure in the literature and medical textbooks and dictionaries.1,2,4,5,6

  1. Francis B, Akil H, Bert B. Ab interno Schlemm’s Canal Surgery. Dev Ophthalmol. 2017;59:127-146.
  2. Ianchulev T, Ahmed IK, Stamper RL, Chang DF, Samuelson TW, Lindstrom R. Innovative Alternatives in the Surgical Management of Glaucoma with Cataract Surgery. Expert Review of Ophthalmology. 2017; 12:5, 403-419, DOI: 10.1080/17469899.2017.1362335.
  3. Sarkisian S, Khaimi M. “Ab Interno Viscodilation of Schlemm’s Canal: VISCO360 and ABiC.” Minimally Invasive Glaucoma Surgery: A Practical Guide. Edited by Francis BA, Sarkisian Jr SR, Tan JC. New York: Thieme, 2017. 145-147. Print. (NOTE: Dr. Sarkisian is a consultant and shareholder in Sight Sciences, the manufacturer of the OMNI Surgical System.)
  4. Baker-Schena L. MIGS: Expanding Options for Glaucoma Treatment. Eye Net (American Academy of Ophthalmology); February 2018. P. 47-53.
  5. Sarkisian S, Allan E. “360-Degree Ab Interno Trabeculotomy” Minimally Invasive Glaucoma Surgery: A Practical Guide. Edited by Francis BA, Sarkisian Jr SR, Tan JC. New York: Thieme, 2017. 104-108. Print.
  6. Trabeculotomy [Def. 1] Stedman’s Medical Dictionary, 1995.

Warnings

1. The OMNI™ System should not be used in cases where there is insufficient visualization of the anterior chamber. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit surgeon view.

2. Monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, appropriate management of intraocular pressure should be initiated, including medication or surgery.

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, 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.

Federal (USA) law restricts this device to sale, distribution, or use by or on the order of a physician.

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info@sightsciences.com

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