Indications: The iTrack™ Advance has been 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. Contradictions: 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; 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 membranedetachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.
Warnings: Do not use the cannula to create an incision in the external tissues. Be careful when taking off the protective cap of the cannula to not break sterility by piercing the surgical drapes or gloves of the surgeon or technicians with the exposed cannula. The fiber optic line and infusion lines must not be pulled as these lines are attached to the back end of the iTrack™ Advance Handle when in use.
Precautions: Do not use product if the tamper proof seal has been broken. Do not use product if the pouch integrity has been broken. Do not remove the protective cover from the cannula until ready to use. Handle the iTrack™ Advance carefully to avoid damaging the device. Do not use product if the cannula cover is not attached to the handpiece. Do not use product if it appears to be damaged. Do not apply excessive force to the cannula cover or the actuator. Do not let the viscoelastic dry at the tip of the microcatheter, as this can cause the lumen to become occluded. Avoid touching the cannula with any surfaces as this may damage the precisely manufactured spatulated tip. Do not bend the cannula. Do not use excessive force when directing the Cannula and maintain visualization of the spatulated tip and microcatheter to avoid contacting and damaging unintended tissues. The microcatheter should be advanced and retracted slowly using the actuator, and the spatulated tip must be positioned correctly to prevent the microcatheter from being kinked or bent. Actuator withdrawal and of viscoelastic flow must be smooth, consistent, and continuous. Maintain visualization of the spatulated tip and microcatheter to avoid unintended tissue damage. When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration.
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.