iStent approved only with cataract surgery

Optometry Times said in a May 22 explainer that the iStent trabecular micro-bypass device is approved only when it is implanted in combination with cataract surgery, a point that can be blurred in broader discussions of minimally invasive glaucoma surgery. The publication described iStent as a tiny titanium trabecular bypass implant placed during phacoemulsification, the standard ultrasound-based cataract procedure. Glaukos, which makes the device, says its iStent inject W is indicated for use in conjunction with cataract surgery in adults with mild-to-moderate primary open-angle glaucoma. FDA device records for iStent inject carry the same indication. ### Which iStent is tied to cataract surgery? Glaukos lists iStent inject W as indicated “in conjunction with cataract surgery” to reduce intraocular pressure in adult patients with mild-to-moderate open-angle glaucoma. The company’s product page does not describe it as a routine standalone implant. FDA records for the iStent inject Trabecular Micro-Bypass System Model G2-M-IS likewise state that it is indicated for use with cataract surgery. (optometrytimes.com) The Optometry Times explainer framed that limitation as a practical point for comanagement. Its description matches longstanding labeling language that ties the implant to a combined cataract-and-glaucoma procedure rather than a separate office or operating-room intervention on its own. ### What exactly is being implanted during the cataract operation? Optometry Times described iStent as a tiny titanium trabecular bypass device intended to be placed during phacoemulsification. (glaukos.com) Glaukos says the system is designed to bypass the trabecular meshwork and improve aqueous outflow through Schlemm’s canal, with the implant delivered during cataract surgery. FDA directions for use for iStent inject describe an injector holding two stents that are implanted one at a time into Schlemm’s canal. (optometrytimes.com) That pairing with cataract surgery is built into the approved use instructions, not presented as an optional add-on in the labeling. ### Does that mean no iStent can ever be used on a standalone basis? The answer is no. Glaukos markets a separate product, iStent infinite, with a different indication. (optometrytimes.com) The company says iStent infinite is intended to reduce intraocular pressure in adults with primary open-angle glaucoma when previous medical and surgical treatment has failed, and it describes that device as a standalone implantable alternative. FDA clearance documents for iStent infinite reflect that indication. (accessdata.fda.gov) That distinction matters because “iStent” is often used loosely in conversation to describe a family of related micro-bypass devices. The approved use depends on the specific model: iStent inject W is labeled for combined use with cataract surgery, while iStent infinite has a separate standalone indication for a narrower, more refractory patient population. ### Why does the labeling distinction matter for comanagement? Optometry Times presented the issue in the context of glaucoma-surgery comanagement, where optometrists and surgeons need to know which procedures are being performed and under what labeling. (glaukos.com) The publication noted limited standalone indications for iStent, which aligns with the split between the cataract-linked iStent inject W and the separately indicated iStent infinite. (glaukos.com) Earlier Optometry Times coverage of MIGS also said iStent inject was approved only in conjunction with cataract surgery, while noting that an increasing number of MIGS procedures overall have gained standalone indications. That broader category trend does not change the approved labeling of the cataract-linked iStent model discussed here. ### Where can readers check the current indication? Glaukos maintains current product pages for iStent inject W and iStent infinite, and FDA device files for both products remain publicly available. (optometrytimes.com) Optometry Times published its latest comanagement explainer on May 22, 2026, pointing readers back to those distinctions as MIGS options continue to expand. (optometrytimes.com)