Sight Sciences, a venture-backed, commercial stage ophthalmic device company, has announced FDA 510(k) clearance for its OMNI Surgical System, a surgical tool dually indicated for the delivery of controlled volumes of viscoelastic fluid as well as the cutting of trabecular meshwork tissue.
The OMNI System is a next-generation technology that combines two distinct functions into one device: (1) controlled viscoelastic delivery anywhere within the anterior segment, including in up to 360 degrees of Schlemm’s canal; and (2) controlled, customizable trabeculotomy. Each of these canal procedures is sufficiently established to have its own Category 1 CPT code, and the OMNI System can be used on a standalone basis or in conjunction with cataract surgery.
“The OMNI System is uniquely designed to target both sources of resistance in the conventional outflow pathway with a single integrated device,” says Nathan Radcliffe, MD, Microincisional Surgery Center of Excellence of New York Eye and Ear Infirmary. “It offers a new, sophisticated solution for two well-established procedures, canaloplasty and trabeculotomy. It will be a welcome and exciting addition to my surgical armamentarium.”
“This is a major milestone for Sight Sciences and further expands our portfolio of solutions for ophthalmologists performing angle surgery,” says Shawn O’Neil, senior vice president of sales and marketing at Sight Sciences. “Our R&D team designed the OMNI System based on feedback from our customers, and we are excited to bring this innovative, multi-procedure technology to the surgical glaucoma market.”