Nova Eye Medical Limited announced it has received 501(K) clearance from the FDA for the iTrack Advance, a new canaloplasty device, for intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma (POAG).
Give me a refresh on the company.
Nova Eye Medical Limited is a medical technology company that develops, manufactures, and sells proprietary ophthalmic treatment technologies and devices across the globe.
How about canaloplasty?
Canaloplasty was first introduced to the US market in 2008 as a stent-free, minimally-invasive glaucoma surgery (MIGS) to reduce IOP in glaucoma patients by treating blockages in the eye’s conventional outflow pathway (such as the trabecular meshwork [TM] and Schlemm’s canal) to improve the aqueous humor’s physiologic outflow.
Now talk about the iTrack.
The iTrack Advance is based on the original iTrack, a novel canaloplasty device that was the first to establish canal surgery for glaucoma.
The technology is designed to treat all sites of outflow resistance within the conventional outflow system of the trabecular meshwork (TM)—including both proximal and distal—effectively separating the compressed trabecular plates with the TM.
What’s new about the iTrack Advance?
While the new device shares the same proprietary features as the original, including a 200-micron illuminated canaloplasty microcatheter, the latest version also includes an ergonomic handpiece that provides improved access into the canal.
This addition enables a surgeon to advance and retract the microcatheter along the full circumference of Schlemm’s canal with greater efficiency.
Any clinical trials to back this up?
Not in the U.S... but a multicenter, randomized study is currently in progress in Germany to assess the iTrack Advance’s effectiveness for canaloplasty when performed with cataract surgery versus cataract surgery alone. See here for details on the CATALYST study (NCT05564091).
The study is also expected to support the use of canaloplasty for treatment of mild-to-moderate glaucoma patients.
Has it been cleared anywhere else yet?
Yes! Since June 2022, the iTrack Advance has been cleared by Canada, Australia, and Europe (including Germany).
What’s next?
Nova Eye plans to immediately commence marketing and sales for iTrack Advance in the United States. The company is also expecting to roll out a full product launch at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in San Diego, May 5-8, 2023.