The US FDA has cleared the new generation iTrack Advance canaloplasty device for canal-based glaucoma surgery from ASX-listed Nova Eye Medical, as the company works to make the technology available a broader range of eye surgeons wishing to combine the procedure with cataract surgery.
The company, who’s registered address is in Adelaide but with manufacturing facilities in California and New Zealand, announced the approval on 31 March 2023.
The original iTrack falls within the minimally invasive glaucoma surgery (MIGS) category and was the pioneering canaloplasty device that Nova Eye says first established canal surgery for glaucoma. To date, approximately 120,000 surgeries have been performed by surgeons worldwide with a proven clinical efficacy and safety profile.
According to the company, the iTrack microcatheter is the only product indicated for canal surgery to treat glaucoma with viscodilation alone.
iTrack Advance is the latest addition to the iTrack family and is a described as a high precision hand-held delivery system that places the iTrack™ microcatheter into the main drainage canal of the eye for injection of viscoelastic fluid (canaloplasty) to clear blockages that cause elevated intraocular pressure.
“The original iTrack is principally used by glaucoma surgeons whereas the new iTrack Advance, with the extended feature set, is expected to appeal to glaucoma surgeons as well as cataract surgeons and comprehensive surgeons, for use in a combination procedure alongside cataract surgery,” Nova Eye stated.
“iTrack Advance can be used by surgeons for both standalone procedures as well as in combination with cataract surgery. With FDA 510(k) clearance secured, Nova Eye can immediately commence marketing and sales of iTrack™ Advance to US ophthalmologists for the treatment of glaucoma.”
A full product launch is planned for the American Society of Cataract and Refractive Surgery (ASCRS) annual conference 5-8 May 5-8, 2023 in San Diego.
“Having pioneered canaloplasty technology with the original iTrack device, Nova Eye is now well positioned to materially penetrate the expanding canal surgery market with iTrack Advance,” Nova Eye Medical managing director Mr Tom Spurling said.
According to Dr Mahmoud Khaimi, a clinical professor affiliated with Dean McGee Eye Institute at the University of Oklahoma, iTrack™ Advance will make the canaloplasty procedure much more accessible to the broader market of cataract and anterior segment surgeons.
“I’ve been given the great opportunity and honour to pair hand-in-hand with Nova Eye to develop the iTrack Advance. We’ve taken the original iTrack device and incorporated it into an ergonomic handpiece that allows surgeons to easily advance and retract the microcatheter through the canal,” he said.
“With this new design we have streamlined the canaloplasty procedure and made it efficient and very ergonomic for the surgeon. I am confident that surgeons will adopt this device into their treatment algorithm, either as an adjunct to cataract surgery or as a standalone procedure.”
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