Nova Eye Medical Announces US Market Clearance of the iTrack Advance Canaloplasty Device

Nova Eye Medical announced that it has been granted FDA 510(k) clearance for its new canaloplasty device, iTrack Advance.

The iTrack Advance has been cleared for microcatheterization and viscodilation to reduce IOP in adult patients with primary open-angle glaucoma.

First introduced into the US market in 2008, canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS) that works with patient physiology to reduce IOP 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 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, according to Nova Eye. A key feature of the iTrack Advance is an ergonomic handpiece.

Mahmoud A. Khaimi, MD, Clinical Professor, James P. Luton, MD Endowed Chair in Ophthalmology at Dean McGee Eye Institute, University of Oklahoma, was the first surgeon in the USA to perform canaloplasty with the new iTrack Advance. The surgeries were performed at the Dean McGee Eye Institute.

“I’ve been given the great opportunity to pair hand in hand with Nova Eye Medical to develop the iTrack Advance. We’ve taken the original iTrack canaloplasty microcatheter and teamed it with an ergonomic handpiece that facilitates improved access into the canal,” Dr. Khaimi said. “Thanks to the handpiece, we can advance the microcatheter and then retract it along the full circumference of Schlemm’s canal with much greater efficiency than ever before."

In the US, the iTrack Advance has been cleared for canaloplasty both with and without concurrent cataract surgery. The iTrack Advance will be officially launched in the US at the American Society of Cataract and Refractive Surgery (ASCRS) in San Diego, May 5-8, 2023.

Outside of the US, the iTrack Advance has been cleared for use since June 2022 throughout Canada, Australia, and Europe, including Germany, where a multicenter, randomized study (“CATALYST”, CTN: NCT05564091) is currently underway to evaluate the effectiveness of canaloplasty with the iTrack Advance performed in combination with cataract surgery, as compared to cataract surgery alone. The CATALYST study is expected to reinforce the clinical utility of canaloplasty in the treatment of mild to moderate glaucoma patients.