The FDA cleared iTrack Advance for microcatheterization and viscodilation to reduce intraocular pressure (IOP). It treats adult patients with primary open-angle glaucoma.
Fremont, California-based Nova Eye designed its newest canaloplasty device to leverage the proprietary features of its original iTrack. That includes a 200-micron illuminated canaloplasty microcatheter. However, the new design aims for improved surgical efficiency with an ergonomic handpiece. Additional improvements to the platform include proprietary illuminated microcatheter technology.
Tom Spurling, Nova Eye Medical managing director, said the company plans to expand its sales and clinical teams in the U.S. This move, expected immediately, aims 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,” Spurling said.
More about the Nova Eye Medical iTrack Advance
Nova Eye’s canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS). It works with patient physiology to reduce IOP. The approach reflects angioplasty, treating blockages in all parts of the eye’s drainage channel. It improves the physiologic outflow of aqueous humor. This contrasts to other MIGS procedures that mechanically alter the outflow of aqueous humor via stent or tissue removal.
Dr. Mahmoud Khaimi, a canaloplasty surgeon, performed the first U.S. surgeries with the new iTrack Advance. They took place at the Dean McGee Eye Institute in Oklahoma.
“I’ve been given the great opportunity to pair hand in hand with Nova Eye Medical to develop the iTrack Advance,” Khaimi said. “We’ve taken the original iTrack canaloplasty microcatheter and teamed it with an ergonomic handpiece that facilitates improved access into the canal. 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.”
Nova Eye plans to officially launch its iTrack Advance in the U.S. at the American Society of Cataract and Refractive Surgery (ASCRS) in San Diego next month. The system already holds clearance throughout Canada, Australia and Europe.