Nova Eye Medical Limited, a medical technology company committed to advanced ophthalmic treatment technologies and devices, has been granted U.S. FDA 510(k) clearance for its new canaloplasty device, iTrackAdvance.

The iTrack Advance has been cleared for microcatheterization and viscodilationto reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma.

First introduced into the U.S. market in 2008, canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS) that works with patient physiology to reduce intraocular pressure in glaucoma patients. Specifically, canaloplasty uses an approach akin to angioplasty to treat blockages in all parts of the eye’s drainage channel, referred to as the conventional outflow pathway – trabecular meshwork, Schlemm’s canal and collector channels – to improve the physiologic outflow of aqueous humor. This is in contrast to other MIGS procedures, which mechanically alter the outflow of aqueous humor via a stent or tissue removal.

Canaloplasty was first brought to the ophthalmological fore in 2008, following the release of the company’s original iTrack canaloplasty microcatheter, which has been used in more than 120,000 canaloplasty procedures globally.

The iTrack Advance

The iTrack Advance leverages the same proprietary features of the company’s original iTrack, including a 200-micron illuminated canaloplasty microcatheter, but has been designed for improved surgical efficiency. A key feature of the iTrack Advance is an ergonomic handpiece.

The company says it is grateful for the continued collaboration with a multi-disciplinary group of surgeons, academics, and industry partners, which has underpinned the development of the iTrack Advance.

In the U.S., the iTrack Advance has been cleared for canaloplasty both with and without concurrent cataract surgery. Given the enhanced ease-of-use and ergonomic design, along with the more streamlined nature of the procedure, it is expected that the iTrack Advance will continue to drive increased surgeon uptake of the canaloplasty procedure.

According to Tom Spurling, managing director of Nova Eye Medical, the company will expand its sales and clinical teams in the U.S. effective immediately, to support the U.S. market introduction of iTrack Advance.

“The U.S. 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 U.S. glaucoma surgeons and anterior segment surgeons,” says Spurling. “Our current priority is to get the device into the hands of these adopting surgeons as quickly as possible.”

Outside of the U.S., the iTrack Advance has been cleared for use since June 2022 throughout Canada, Australia, and Europe.