Sight Sciences Announces Health Canada Approval of the VISCO™360 Viscosurgical System for Standalone Microinvasive Glaucoma Surgery (MIGS)
Successful First VISCO™360 Cases in Canada Performed by Dr. Ike Ahmed Using the Breakthrough Revolving, 360-degree Ahmed Gonioprism
MENLO PARK, California, April 13, 2017 /PRNewswire/ -- Sight Sciences, Inc., a venture-backed, commercial stage ophthalmic medical device company announced today that it has received Health Canada approval for the VISCO™360 Viscosurgical System. The VISCO360 System is indicated in Canada for the microcatheterization and transluminal viscodilation of Schlemm's canal to reduce intraocular pressure (IOP) in adult patients with open-angle glaucoma.* Performed as a standalone MIGS procedure, the first commercial VISCO360 cases in Canada were successfully carried out by Dr. Ike Ahmed, world-renowned ophthalmologist recognized for his extensive experience in the diagnosis and surgical treatment of glaucoma. The VISCO360 cases were performed using Dr. Ahmed's breakthrough lens that offers a high-resolution view of all 360 degrees of the iridocorneal angle and can track microcatheters as they are advanced around Schlemm's canal. The Ahmed 360-degree gonioprism has another advantage of not requiring the tilting of the patient's head or operating microscope.
"Catheterizing and viscodilating Schlemm's canal by way of the more efficient ab interno approach is a safe and exciting new MIGS procedure," explains Dr. Ike Ahmed, Head of Ophthalmology at Trillium Health Partners and the University of Toronto and Professor at the University of Utah. "The VISCO360 System simplifies canaloplasty and allows for complete access to Schlemm's canal using a single clear corneal incision and a single-handed device. The VISCO360 procedure couples nicely with my new 360-degree gonioprism that allows real-time view of the microcatheter as it circumnavigates and viscodilates the entire trabeculocanalicular outflow system."
The VISCO360 Viscosurgical System offers ophthalmologists a user-friendly, clear corneal approach to canaloplasty, a glaucoma procedure with a well-established safety and efficacy profile. "Receiving Health Canada approval for the VISCO360 System and working with Dr. Ike Ahmed on our first commercial cases in Canada using his revolutionary 360-degree gonioprism are important milestones for our company and, more importantly, for the treatment of patients with glaucoma," stated Paul Badawi, Founder and CEO of Sight Sciences. "We are looking forward to working more closely with Dr. Ahmed and commercializing the VISCO360 Viscosurgical System in conjunction with the upcoming commercial release of the 360-degree, tilt-free gonioprism."
Click here to view Dr. Ike Ahmed using his revolving gonioprism to microcatheterize and viscodilate Schlemm's canal using the VISCO360 Viscosurgical System.
The VISCO360 System is a fully-integrated, single-handed, single-use device that offers a single-incision, 360-degree canal procedure. The system combines a custom access cannula, a soft and flexible microcatheter with an atraumatic tip, an internal infusion pump, gear mechanism, and viscoelastic reservoir, and a wheel that controls advancement and retraction of the microcatheter using only a single finger.
Glaucoma is the world's leading cause of irreversible blindness and affects approximately 80 million people worldwide. Often associated with abnormally high intraocular pressure, glaucoma is characterized by progressive vision loss due to irreversible optic nerve damage. 80% of people with glaucoma do not have co-existing cataracts making a standalone surgical option like VISCO360 an important part of an ophthalmologist's armamentarium.
About Sight Sciences: Sight Sciences is a medical device company serving the ophthalmic community and dedicated to the development of technology-driven solutions that address the underlying physiology of eye diseases. Its surgical product portfolio consists of the TRAB™360 and VISCO™360 surgical systems. For more information, visit www.sightsciences.com.
*The VISCO™360 Viscosurgical System and the TRAB™360 Trabeculotomy System have received CE Mark and Health Canada approvals and are commercially available in Canada and countries recognizing the CE Mark, or applicable healthcare authority registrations. The VISCO™360 Viscosurgical System is commercially available in the United States as a manual surgical tool for the precise delivery of viscoelastic fluid into the anterior segment. The company has an IDE clinical trial underway in the United States to study the use of the VISCO360 device for the specific indication of IOP reduction in adult, pseudophakic patients with primary open angle glaucoma.
Share this article