iStent infinite^®: The Micro-Invasive Alternative for Interventional Glaucoma

The iStent infinite^® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce intraocular pressure (IOP) of the eye. It is the first-of-its-kind standalone implantable alternative, meaning that it can be used in a standalone setting or in combination with cataract surgery. Not restricted to stage of disease, iStent infinite can deliver powerful efficacy on tough-to-treat patients who would otherwise likely need more invasive treatment, which carries significant post-op risk and complication management (1).

Today, patients in need of standalone glaucoma surgery have limited micro-invasive options to treat their condition. iStent infinite addresses that gap in the treatment algorithm. In a prospective, multi-center, 12-month pivotal trial, patients with open-angle glaucoma who had failed prior medical and surgical intervention – and who had a significantly higher preoperative treatment burden with more severe glaucoma compared to other trabecular bypass MIGS pivotal trials – underwent standalone iStent infinite implantation (2,4,6). Of these patients, 73.4 percent showed a ≥ 20 percent reduction in IOP, while 47.3 percent showed a ≥ 30 percent reduction in IOP (3). The device demonstrated sustained efficacy throughout the course of the study, as well as exceptional intraoperative and postoperative safety among patients with two or more prior failed filtering surgeries (2,5). The study further showed that only 4.9 percent of eyes (n=3) required secondary surgical intervention following iStent infinite implantation through 12 months, despite multiple failed prior surgical interventions.

With three anatomically designed stents preloaded into an injector system, the device’s powerful technology delivers foundational, 24/7, long-term control of IOP in patients with glaucoma who have failed prior medical and surgical intervention. iStent infinite is designed to maximize outflow while minimizing disruption to natural anatomy by occupying only 3% of the trabecular meshwork, thereby leaving 97% untouched. Coupled with its patented multidirectional stent design, this helps bypass resistance and restore physiologic outflow by creating arcs of flow spanning up to 8 clock hours (240°) while minimizing tissue disruption – thus offering broad coverage compared with other MIGS procedures. The device’s injector system was redesigned to allow an unlimited number of stent delivery attempts, giving surgeons confidence and peace of mind, no matter where they are in their learning curve.

The iStent infinite is the first-of-a-kind, standalone implantable alternative to medications and more invasive procedures, giving surgeons the versatility to treat a variety of patients, while helping to address rampant rates of patient noncompliance and disease progression. In short, iStent infinite is more than just its features and benefits,* it is the beginning of the interventional glaucoma revolution!

* INDICATION FOR USE. The iStent infinite^® Trabecular Micro- Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. CONTRAINDICATIONS. The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS.

Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

©2024 Glaukos Corporation. All rights reserved. Glaukos and iStent infinite are registered trademarks of Glaukos Corporation. All other trademarks are the property of their respective owners.

PM-GL-0106

www.glaukos.com