iTrack Advance

Primary DI

00893872001615

Basic UDI-DI Code

B-00893872001615

Reference

iTrack-ADS

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Nova Eye, Inc.

The iTrack™ Advance, is a sterile, single use system comprised of a Canaloplasty Microcatheter preloaded into an ergonomic Handheld Cannula and supplied with an Ophthalmic ViscoInjector™. • The Canaloplasty Microcatheter is a flexible microcatheter designed for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma. • The ergonomic Handheld Cannula enables the physician to insert and retract the Microcatheter with a single hand using the actuator on the Handle of the Body to propel the catheter. The Handheld Cannula has a curved and spatulated tip to aid insertion of the microcatheter directly into Schlemm’s canal. • The Ophthalmic ViscoInjector™ permits administration of viscoelastic directly into Schlemm’s canal delivered through the Microcatheter. The iTrack™ Advance is designed to interface to a re-useable endoilluminator (the iLumin™) to illuminate the tip of the microcatheter, providing a visual indication to the surgeon of the position of the microcatheter tip within the canal.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).