Eyeworld

To learn more, contact Glaukos at 800.452.8567 or visit www.glaukos.com. NOT A HOLE. A PATHWAY FORWARD. Innovation is not static. One step leads to another as new technologies work in tandem with evolving clinical techniques to elevate performance and optimize outcomes. Today, clinicians are using the iStent ® Trabecular Micro-Bypass Stent to target conventional pathways and reestablish physiologic outfl ow. iStent is more than just an innovative trabecular micro-bypass stent, it is a step forward to safe and effective glaucoma treatment. INDICATION FOR USE. The iStent ® Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. CONTRAINDICATIONS. The iStent ® is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, 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 PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent ® is MR-Conditional meaning that the device is safe for use in a specifi ed MR environment under specifi ed conditions; please see label for details. PRECAUTIONS. The surgeon should monitor the patient post-operatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent® has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with signifi cant prior trauma, chronic infl ammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after "washout" of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually signifi cant cataract. ADVERSE EVENTS. The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ≥ 1 line at or after the 3-month visit (7%), posterior capsular opacifi cation (6%), stent obstruction (4%) early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information. CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events. ©2015 Glaukos Corporation. Glaukos and iStent are registered trademarks of Glaukos Corporation.

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