Sam Brusco, Associate Editor04.12.23
Ophthalmic treatment and device company Nova Eye Medical has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its iTrack Advance canaloplasty device. It was cleared for microcatheterization and viscodilation to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma.
Canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS) that works with physiology to reduce IOP in glaucoma patients. It uses an approach like angioplasty to treat blockages in the eye’s drainage channel—trabecular meshwork, Schlemm’s canal, and collector channels—to boost physiological outflow of aqueous humor.
The company’s original iTrack canaloplasty microcatheter was released in 2008 and has been used in over 120,000 procedures yearly. iTrack advance includes a 200-micron illuminated canaloplasty microcatheter but was designed to improve surgical efficiency. A key feature is an ergonomic handpiece.
Dr. Mahmoud A. Khaimi, Clinical Professor, James P. Luton, MD Endowed Chair in Ophthalmology at Dean McGee Eye Institute, University of Oklahoma was the first surgeon in the U.S. 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,” he told the press. “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.”
“Another important point is that surgeons will continue to benefit from Nova Eye’s proprietary illuminated microcatheter technology,” he continued. “First debuted with the original iTrack™ and now with the iTrack Advance, it is the world’s only illuminated canaloplasty microcatheter. Being able to track where the microcatheter is at all times makes a significant impact during surgery. I liken it to driving at night without headlights. You’d never choose to drive without the assurance and safety of headlights.”
Canaloplasty is a stent-free, minimally invasive glaucoma surgery (MIGS) that works with physiology to reduce IOP in glaucoma patients. It uses an approach like angioplasty to treat blockages in the eye’s drainage channel—trabecular meshwork, Schlemm’s canal, and collector channels—to boost physiological outflow of aqueous humor.
The company’s original iTrack canaloplasty microcatheter was released in 2008 and has been used in over 120,000 procedures yearly. iTrack advance includes a 200-micron illuminated canaloplasty microcatheter but was designed to improve surgical efficiency. A key feature is an ergonomic handpiece.
Dr. Mahmoud A. Khaimi, Clinical Professor, James P. Luton, MD Endowed Chair in Ophthalmology at Dean McGee Eye Institute, University of Oklahoma was the first surgeon in the U.S. 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,” he told the press. “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.”
“Another important point is that surgeons will continue to benefit from Nova Eye’s proprietary illuminated microcatheter technology,” he continued. “First debuted with the original iTrack™ and now with the iTrack Advance, it is the world’s only illuminated canaloplasty microcatheter. Being able to track where the microcatheter is at all times makes a significant impact during surgery. I liken it to driving at night without headlights. You’d never choose to drive without the assurance and safety of headlights.”