Glaukos Corporation to receive Pre-Market approval for Next-Gen iStent

June 26, 2018  Source: BioSpectrumAsia 195

California-based Glaukos Corporation announced that it has received premarket approval (PMA) from the Food and Drug Administration for its new iStent inject Trabecular Micro-Bypass System which is aimed at treatment of intraocular pressure (IOP),  a disease of the eye in which fluid pressure within the eye rises, in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery. The company mainly focuses on an ophthalmic medical technology, and pharmaceutical therapies designed to transform the treatment of glaucoma.

The iStent inject is developed to achieve the natural outflow of aqueous humor by making two patent bypasses through the trabecular meshwork, glaucomatous eyes the main source of resistance resulting in multi-directional flow through Schlemm’s canal. The iStent contains two heparin-coated titanium stents preloaded into an auto-injection, which will enable the ophthalmologists to accurately implant stents into two trabecular meshwork locations via single corneal entry point in a straightforward click-and-release motion.

The new development will be Glaukos Next-gen trabecular micro-bypass technology which is based on the same fluidic method of action like first-gent iStent, launched in 2012 and has implanted over 400,000 eyes worldwide since its introduction.

Each iStent inject stent is closely 0.23 mm x 0.36 mm, as per the company the iStent inject is the smallest medical device ever approved by the FDA.

By Ddu
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