The iTrack™ has a CE Mark (Conformité Européenne) 2862 and US Food and Drug Administration (FDA) 510(k) #K080067 for the treatment of open-angle glaucoma.
INDICATIONS: The iTrack™ canaloplasty microcatheter is cleared for the indication of fluid infusion and aspiration during surgery, and for 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.
