Glaukos Announces FDA 510(k) Clearance of iPRIME Viscodelivery System

Glaukos announced that it has received 510(k) clearance from the FDA for the iPRIME Viscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery.

“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. We are thrilled to announce this clearance as we believe iPRIME will be another important tool that supports the needs of physicians and patients,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “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.”