INDICATIONS:
The iTrack™ canaloplasty microcatheter has been cleared for the indication of fluid infusion and aspiration during surgery.
The iTrack™ canaloplasty microcatheter has been cleared for the indication of catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.
CONTRAINDICATIONS:
The iTrack™ canaloplasty microcatheter 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; and, previous surgery with resultant scarring of Schlemm’s canal.
ADVERSE EVENTS:
Possible adverse events with the use of the iTrack™ canaloplasty microcatheter 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.
WARNINGS:
The iTrack™ canaloplasty microcatheter is intended for one time use only. DO NOT re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
PRECAUTIONS:
The iTrack™ canaloplasty microcatheter 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.
CAUTION:
Federal law restricts this device to sale by, or on the order of, a physician. Please see IFU for a complete list of contraindications, warnings, precautions, and adverse events.