Nova Eye secures FDA 510(k) approval for iTrack Advance canaloplasty device

2023-04-13

上市批准

iTrack Advance device is indicated for microcatheterisation and viscodilation of Schlemm canal, also known as canaloplasty, to reduce intraocular pressure (IOP) in adult patients suffering from primary open-angle glaucoma Nova Eye secures FDA 510(k) approval for iTrack Advance canaloplasty device. (Credit: Olga Guryanova on Unsplash) Australia-based ophthalmic devices company Nova Eye Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its new-generation canaloplasty device, iTrack Advance. The iTrack Advance is indicated for microcatheterisation and viscodilation of Schlemm canal, also called canaloplasty, 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 patient physiology to reduce intraocular pressure in glaucoma patients. The procedure leverages an approach similar to angioplasty to treat blockages in all parts of the eye’s drainage channel to improve the physiologic outflow of aqueous humour. The drainage channel, also known as the conventional outflow pathway, includes trabecular meshwork, Schlemm’s canal and collector channels. The US health agency approved the next-generation device to deliver canaloplasty both with and without concurrent cataract surgery. Nova Eye Medical managing director Tom Spurling said: “The company will expand its sales and clinical teams in the US effective immediately, to support the US market introduction of iTrack Advance. “The US 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 US glaucoma surgeons and anterior segment surgeons. “Our current priority is to get the device into the hands of these adopting surgeons as quickly as possible.” In 2008, the ophthalmic technology company rolled out its original iTrack canaloplasty microcatheter, which has been used in more than 120,000 canaloplasty procedures. The iTrack Advance leverages the same unique features of the original iTrack, including a 200-micron illuminated canaloplasty microcatheter. Nova Eye said that the upgraded version has been designed to feature an ergonomic handpiece to deliver improved surgical efficiency. Mahmoud A Khaimi is the first surgeon to perform canaloplasty using the new iTrack Advance device in the US, at the Dean McGee Eye Institute. Khaimi said: “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.” “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.”

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