Glaukos’ iStent infinite Device Cleared

Glaukos Corporation has received 510(k) clearance from the FDA for its iStent infinite system for reducing intraocular pressure in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy.

The system features three heparin-coated titanium stents preloaded into an auto-injector that allows the surgeon to inject stents around the eye’s primary drainage channel. The stents lower intraocular pressure by restoring the natural outflow of aqueous humor, the clear fluid that fills the space in the front of the eyeball between the lens and the cornea.

The company said this device is the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing cataract surgery.

The company plans to launch the product later this year.