Glaukos Receives FDA 510(k) Clearance of the iStent Infinite MIGS Device

MIGS founder announces the first-ever micro-invasive implantable device for standalone glaucoma treatment.

Glaukos announced that it has received 510(k) clearance from the FDA for the iStent infinite Trabecular Micro-Bypass System. The iStent infinite is indicated for use in a standalone procedure to reduce elevated IOP in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy.

The iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the glaucoma surgeon to inject stents across a span of up to approximately 6 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,” 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.”

The procedure should be available to patients next year.

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company based in San Clemente, California that develops novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012.


Source: Eyewire News

Posted on August 5, 2022