CANALOPLASTY FOR STENT-FREE, TISSUE SPARING MIGS

Featuring microcatheters crafted from a specially developed, polymeric compound, the iTrack™ family of canaloplasty devices offers much greater malleability and manoeuvrability than common nylon alternatives. What’s more, the meticulously researched self-lubricious coating to each iTrack™ microcatheter was formulated specifically to enable smooth passage through Schlemm’s canal.

That unyielding focus on precision continues within the microcatheter itself, where the highly sensitive optic-fibre filament sits in parallel to the internal guide wire allowing for a full 360º catheterization of Schlemm’s canal.

The iTrack’s highly advanced distal shaft is also completely fashioned by hand under microscope in our own labs, to a diameter of nominally 200 microns (μm).

The iTrack^™ Advance has a US Food and Drug Administration (FDA) 510(k) and CE Mark (Conformité Européenne) for the treatment of open-angle glaucoma.

Indications for Use, 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.

Indications for Use, 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.
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.