The FDA granted 510(k) clearance for the iStent infinite trabecular micro-bypass system to reduce IOP as a stand-alone procedure for uncontrolled primary open-angle glaucoma, according to a press release from Glaukos.
With the iStent infinite, surgeons inject three heparin-coated titanium stents up to approximately 6 clock hours around Schlemm’s canal to restore the natural outflow of aqueous humor. The mechanism of action is similar to the two-stent iStent inject trabecular micro-bypass system, which is implanted in patient undergoing concomitant cataract surgery.
“This FDA