Glaukos Submits IDE Application to FDA to Study iStent infinite Trabecular Micro-Bypass System

Glaukos Corporation, an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) seeking authorization to study its iStent infinite Trabecular Micro-Bypass System.
 
The iStent infinite is designed for use as a standalone procedure to reduce elevated intraocular pressure (IOP) in refractory glaucoma patients. It includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of five to six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor.
 
“We look forward to working cooperatively with the FDA as they review our IDE application