The iTrack™ Advance has a CE Mark (Conformité Européenne) 2862 and US Food and Drug Administration (FDA) 510(k) #K221872 for the treatment of open-angle glaucoma.
INDICATIONS (International): The iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma.
CONTRAINDICATIONS (International): 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.
ADVERSE EVENTS (International): Possible adverse events with the use of the iTrack™ Advance include, but are not limited to: hyphema, elevated IOP, Descemet’s membrane detachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.
PRECAUTIONS (International): 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
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iTrack™ Advance, iTrack™, ViscoInjector™ and iLumin™ are trademarks of Nova Eye,Inc.
