Glaukos this week announced it received FDA 510(k) clearance for its iStent Infinite trabecular micro-bypass system.
The FDA clearance indication is for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients who have primary open-angle glaucoma.
San Clemente, California-based Glaukos designed iStent Infinite with three heparin-coated titanium stents that are preloaded into an auto-injection system that allows surgeons to deploy stents around the eye’s primary drainage channel, Schlemm’s canal. Once the stents are in place, the device lowers IOP by restoring the natural outflow of aqueous humor.
iStent Infinite is designed with similar mechanisms of action to its previous two-stent iStent Inject W trabecular micro-bypass system that is FDA approved for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
“This FDA clearance for iStent Infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,” CEO Thomas Burns said in a news release. “Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent Infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need. We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent Infinite to the U.S.”
Glaukos will commence initial commercial launch of the device later this year.