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.
INDICATION FOR USE: The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The Nova Eye iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma. The Nova Eye Ophthalmic ViscoInjector™ is a manually operated device for precision delivery of small amounts of fluid such as a sterile viscoelastic solution in a cartridge.
CONTRAINDICATIONS: The Nova Eye 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; Multiple argon laser trabeculoplasty (ALT) procedures; Chronic uveitis; OAG with narrow angle (Note: unless Shaffer Grade of 2 and combined with phacoemulsification); Narrow inlet with plateau iris.
WARNINGS: Do not use the cannula to create an incision in the cornea or other 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 pull the black fiber optic line or grab onto the hub until the assembly has been fully removed from the packaging to avoid damage. 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. Ensure the fiber optic line is not in a path that can be pulled or tripped on. Avoid touching the Cannula with any surfaces as this may damage the precisely manufactured Spatulated Tip. Do not bend cannula. Do not use excessive force when directing the Cannula and maintain visualization of the Spatulated Tip to avoid contacting unintended tissues. 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 slowly and the Spatulated Tip must be positioned correctly to prevent the microcatheter from being kinked or bent. Actuator withdrawal and viscoelastic flow must be smooth, consistent, and continuous. If the microcatheter does not move forward and out of the cannula then discard the iTrack System and proceed to use another device. When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration.
POTENTIAL ADVERSE EVENTS: All of the fluid and tissue contact materials used in the iTrack™ Advance are well tolerated in human and animal studies. Possible adverse events with the use of the iTrack™ Advance include, but are not limited to, the following: Hyphema; Elevated IOP ; Descemet’s membrane detachment; Shallow or flat anterior chamber; Hypotony; Trabecular meshwork rupture; Choroidal effusion; Peripheral anterior synechiae; Iris prolapse; Pupil displacement; Suprachoroidal hemorrhage; Astigmatism; Inadvertent bleb.
Should any information regarding the quality of the products or their uses be required, or to report an adverse event or product quality problem, please contact your local representative or directly contact the manufacturer.
iTrack™ has a CE Mark (Conformité Européenne) and US Food and Drug Administration (FDA) 510(k) # K080067 for the treatment of open-angle glaucoma.
INDICATIONS: The iTrack™ canaloplasty microcatheter 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.
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.
Should any information regarding the quality of the products or their uses be required, or to report an adverse event or product quality problem, please contact your local representative or directly contact the manufacturer.
