The U.S. Food and Drug Administration granted 510(k) clearance for the iStent infinite (Glaukos) 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, according to a company press release.
“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 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 US.”
The company intends to commence initial commercial launch activities for iStent infinite later this year.
Read the full press release here.
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