Nova Eye Medical announces FDA clearance in the US market for iTrack Advance

(Image Credit: Nova Eye Medical)

Nova Eye Medical Limited, announced that it has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its iTrack™ Advance, a new canaloplasty device.

According to a release from the company¹, iTrack™ Advance has been cleared for microcatheterization and viscodilation to reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma.

Canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS) that works with patient physiology to reduce intraocular pressure in glaucoma patients. Canaloplasty uses an approach like angioplasty to treat blockages in all parts of the eye’s drainage channel, referred to as the conventional outflow pathway to improve the physiologic outflow of aqueous humor. This contrasts with other MIGS procedures, which mechanically alter the outflow of aqueous humor via a stent or tissue removal.

According to the company, iTrack™ Advance leverages the same proprietary features of the Company’s original iTrack™, which has been used in more than 120,000 canaloplasty procedures. This includes a 200-micron illuminated canaloplasty microcatheter, but iTrack™ Advance has been designed for improved surgical efficiency. One of the key features of the iTrack™ Advance is an ergonomic handpiece.

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

“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,” said, Khaimi. “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.”

According to the company, 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.

References:

1. Nova Eye Medical Announces U.S. Market Clearance of the iTrack™ Advance Canaloplasty Device. Press release. Nova Eye Medical; April 12, 2023. Accessed April 13, 2023. https://www.businesswire.com/news/home/20230411005839/en/