Glaukos (NYSE:GKOS) announced that it received FDA 510(k) clearance for its iPrime viscodelivery system.
San Clemente, California-based Glaukos designed the iPrime viscodelivery system as a sterile, single-use, minimally invasive device for delivering viscoelastic fluid during ophthalmic surgery.
Glaukos develops medical devices and pharmaceuticals centered around novel therapies for treating glaucoma, corneal disorders and retinal diseases.
Among the company’s offerings is the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. The company submitted a supplemental premarket approval application to the FDA for iStent Infinite in September 2021.
“Since the introduction of our first iStent Trabecular Micro-Bypass Stent in 2012, Glaukos has pioneered the MIGS marketplace and led a transformation in the way ophthalmic surgeons manage chronic eye diseases,” Glaukos President & CEO Thomas Burns said in a news release. “We are thrilled to announce this clearance as we believe iPrime will be another important tool that supports the needs of physicians and patients.
“This technology further expands Glaukos’ broad portfolio of innovative ophthalmic solutions and is consistent with our longstanding position on the value of truly minimally-invasive therapy.”