Venture-backed ophthalmic medical device company Sight Sciences said last week it won Health Canada approval for its TRAB 360 trabeculotomy system.
The TRAB 360 system is now cleared for the microcatheterization of the Schlemm’s canal and cutting of trabecular meshwork to lower intraocular pressure in open angle glaucoma patients, the Menlo Park, Calif.-based company said.
“My first cases with the TRAB 360 were all successful and my patients are doing well in terms of both pressure lowering and a reduction in medications. The device is elegant in design and the circumferential goniotomy procedure is restorative to the entire natural outflow pathway and is blebless in nature. Given its unique ability to access all 360 degrees of diseased meshwork from an ab interno approach, the TRAB 360 is an attractive, less invasive option for my glaucoma patients with moderate to advanced disease,” Dr. Paul Harasymowycz of the University of Montreal said in prepred remarks.
Sight Sciences said that the TRAB 360 system is designed to allow surgeons to complete full 360-degree trabeculotomies from a single corneal incision.
“We are very pleased to learn of Dr. Harasymowycz’ successful first cases in Canada with the TRAB 360 System. We are excited to work with Dr. Harasymowycz and other thought leaders within the global glaucoma community to raise awareness around this comprehensive 360-degree procedure that improves the natural aqueous outflow pathway and requires only a single clear corneal incision to perform,” CEO Paul Badawi said in a press release.
In July, Sight Sciences said it won FDA investigational device exemption approval to initiate a clinical trial of its Visco 360 Viscosurgical System for treating patients with glaucoma.
The multi-center, randomized trial will compare ab interno canaloplasty with the Visco 360 system against selective laster trabeculoplasty. The study will investigate the safety and effectiveness of the Visco 360 system in canaloplasty versus SLT for reducing intraocular pressure in primary open angle glaucoma patients, the company said.
