The iTrack™ Advance has a CE Mark (Conformité Européenne) and US Food and Drug Administration (FDA) 510(k) #K221872 for the treatment of open-angle glaucoma.
INDICATIONS (USA): The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The Nova Eye iTrack™ Advance is indicated for the cutting or disruption of the trabecular meshwork during goniotomy procedures. The Nova Eye iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.* The iTrack™ Advance cutting function (goniotomy) is a Class 1 510(k) exempt device function that is not specifically indicated for the reduction of intraocular pressure (IOP) or the treatment of open-angle glaucoma.CONTRAINDICATIONS: The iTrack™ Advance is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: Neovascular glaucoma; Angle-closure glaucoma; Previous surgery with resultant scarring of Schlemm’s canal.PRECAUTIONS: The iTrack™ Advance should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome.
For full safety information, visit: https://itrack-advance.com© 2025. Nova Eye, Inc. E&OE. Patents pending and/or granted.iTrack™ Advance, iTrack™, ViscoInjector™ and iLumin™ are trademarks of Nova Eye, Inc.
