Nova Eye Medical’s iTrack Advance is indicated for micro-catheterisation and viscodilation of Schlemm’s canal in primary open-angle glaucoma adult patients. Credit: JAFAR AHMED on Unsplash.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Nova Eye Medical’s iTrack Advance canaloplasty device.

The iTrack Advance has been approved for micro-catheterisation and viscodilation of Schlemm’s canal for reducing intraocular pressure (IOP) in primary open-angle glaucoma adult patients. It has been approved to provide canaloplasty both with and without concurrent cataract surgery.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Introduced in the US in 2008, canaloplasty is a stent-free, minimally invasive surgical method to reduce IOP in glaucoma patients and restore the function of the eye’s natural outflow system.

It leverages a technique similar to angioplasty for the treatment of blockages in the ocular outflow pathway for improving the physiologic outflow of aqueous humour.

Nova Eye Medical stated that the next-generation canaloplasty device retains a 200-micron illuminated canaloplasty micro-catheter and among other features of its original iTrack.

See Also:

The iTrack Advance is designed to offer improved surgical efficiency and includes an ergonomic handpiece.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Nova Eye Medical managing director Tom Spurling said: “The company will expand its sales and clinical teams in the US effective immediately to support the US market introduction of iTrack Advance.

“The US clearance of iTrack Advance is a significant milestone for our business and comes at a time when, due to its stent-free, tissue-sparing approach, the canaloplasty procedure is rapidly being adopted into the glaucoma treatment algorithm by a growing number of US glaucoma surgeons and anterior segment surgeons.

“Our current priority is to get the device into the hands of these adopting surgeons as quickly as possible.”

Scheduled for launch in the US next month, the device has already received approval for use in Australia, Canada and Europe.

It is currently being investigated in the CATALYST Study, a multi-centre, randomised trial.

The trial is designed to assess the effectiveness of canaloplasty using the iTrack Advance performed along with cataract surgery compared to cataract surgery alone.