Nova Eye Medical designs, develops, manufactures and markets a portfolio of proprietary glaucoma treatment technologies. Underpinning each of these technologies is our commitment to advance clinical outcomes and improve patient quality of life.
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.
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