Sam Brusco, Associate Editor08.04.22
Glaukos has received U.S. Food and Drug Administration (FDA) clearance for its iStent infinite trabecular micro-bypass system to be used in a standalone procedure to lower elevated intraocular pressure (IOP) for primary open-angle glaucoma uncontrolled by previous medical and surgical therapy.
iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system to inject stents across a span of up to about six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents lower IOP by restoring the natural, physiological outflow of aqueous humor.
“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,” Thomas Burns, Glaukos’ chairman and CEO told the press. “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 aims to begin iStent infinite’s commercial launch later this year.
iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system to inject stents across a span of up to about six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents lower IOP by restoring the natural, physiological outflow of aqueous humor.
“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,” Thomas Burns, Glaukos’ chairman and CEO told the press. “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 aims to begin iStent infinite’s commercial launch later this year.