Glaukos’ iStent Infinite Receives FDA 510(k) Clearance

Glaukos’ iStent Infinite Receives FDA 510(k) Clearance

August 05, 2022

The FDA has granted 510(k) clearance for the iStent infinite Trabecular Micro-Bypass System, according to a news release from Glaukos. The iStent infinite is designed for use in a standalone operation to lower increased IOP in patients with primary open-angle glaucoma who have not been managed by prior medicinal and surgical therapy.

The iStent infinite has three titanium stents that have been coated with heparin which are preloaded into an auto-injection system that enables the surgeon to inject stents over the course of up to six clock hours along Schlemm's canal.

Once implanted, the stents are intended to reduce IOP by resuming the aqueous humor's normal, physiological outflow.

The two-stent iStent inject W Trabecular Micro-Bypass System, manufactured by the same company, and approved by the FDA for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma who are undergoing concurrent cataract surgery, shares a similar mechanism of action with the iStent infinite.

“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, chairman and chief executive officer, said in a company 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.,” Mr. Burns further added.

The company plans to begin initial commercial launch activities for iStent infinite later this year.