iStent infinite Trabecular Micro-Bypass System is intended for use in standalone surgery for patients with primary open-angle glaucoma whose increased intraocular pressure (IOP) is uncontrolled by earlier medication and surgical therapy
Ophthalmic medical technology company Glaukos has received 510(k) clearance from the US Food and Drug Administration (FDA) for the iStent infinite Trabecular Micro-Bypass System.
The system is intended for use in standalone surgery for patients with primary open-angle glaucoma whose increased intraocular pressure (IOP) is uncontrolled by earlier medication and surgical therapy.
The iStent infinite has three titanium stents that have been coated with heparin that are preloaded into an auto-injection system.
Glaukos said the device enables the surgeon to inject stents over a period of up to six clock hours around Schlemm’s canal, the main drainage path for the eye.
Once implanted, the stents are intended to reduce IOP by resuming the aqueous humour’s normal, physiological outflow.
The system shares a similar mechanism of action with its FDA-approved two-stent iStent inject W Trabecular Micro-Bypass System designed for the reduction of IOP in adults with open-angle glaucoma who are undergoing cataract surgery.
Glaukos chairman and chief executive officer Thomas Burns said: “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.
“Supported by strong pivotal data highlighting favourable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons with 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 plans to start the launch activities for the commercial rollout of iStent infinite later this year.
In January this year, the company received 510(k) clearance from the US Food and Drug Administration for the iPRIME Viscodelivery System designed for the delivery of viscoelastic fluid during ophthalmic surgery.