The iStent infinite Trabecular Micro-Bypass System, indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy, has received 510(k) clearance from the United States Food and Drug Administration (FDA).
Glaukos’ iStent infinite includes three heparin-coated titanium stents, preloaded into an auto-injection system, allowing surgeons to inject stents across a span of up to approximately six clock hours around Schlemm’s canal. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite has a similar mechanism of action to the company’s two-stent iStent inject W Trabecular Micro-Bypass System, which is approved by the FDA 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,” said Thomas Burns, chairman and chief executive officer. “Supported by strong pivotal data highlighting favourable 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.”
Glaukos intends to commence initial commercial launch activities for iStent infinite later this year.
