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