iTrack™ Advance has a CE Mark, CE 2862 (Conformité Européenne) and US Food and Drug Administration (FDA) 510(k) # K221872 for the treatment of open-angle glaucoma.
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 iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The iTrack™ Advance is indicated for the cutting or disruption of the trabecular meshwork during goniotomy procedures.* The iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.
The ab interno surgical technique is not a cleared indication for the iTrack™ Advance in the USA.
* 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 (USA): 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 (USA): 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.
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.
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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