iStent® for Glaucoma Microtechnology advancement for mild to moderate open-angle glaucoma What is iStent? iStent is the world’s smallest medical implant designed to treat open-angle glaucoma in a new way by helping to relieve the pressure caused by fluid build-up in the eye. Too much fluid raises pressure and can cause the gradual loss of vision. Click the play button to learn more about iStent® Trabecular Micro-Bypass How does iStent work? Like other stents used to prevent heart attacks and strokes, the iStent creates a permanent opening to prevent blockage and improve the eye’s natural drainage. This helps to control pressure in the eye. How is iStent implanted? iStent is implanted during cataract surgery. It is so tiny that it is not noticed by the patient. What the patient will notice is that there is no longer a need to put one, two or even three different types of drops in the eye every day. Drops Dropped Studies have shown that more than 90% of patients do not comply with their ocular medication dosing regimens and nearly 50% discontinue taking their medications. How small is the iStent? It is so small that it appears like a speck to the naked eye, much smaller than the intraocular lens that is implanted during cataract surgery. Who can get the iStent implant? This is designed only for patients who have mild to moderate open-angle glaucoma that is being treated with ocular hypotensive medications (eye drops). It is implanted during cataract surgery. What are the benefits? This iStent is designed to increase the flow of fluid, limit vision loss and reduce if not totally eliminate the use of glaucoma drops which are an ongoing expense. Implanting during cataract surgery offers you two vision benefits in a single surgery. Stent Success In a U.S. clinical study, 68% of glaucoma patients who received iStent remained medication free at 123 months while sustaining a target intraocular pressure of < 21 mm Hg vs. only 50% of patients who underwent cataract surgery alone. The following WK Eye Institute doctors offer this procedure: Wyche T. Coleman, III, M.D. Ophthalmologist South David D. Bryan, M.D. Ophthalmologist Pierremont Christopher L. Shelby, M.D. Ophthalmologist North, Pierremont Stephen W. Lewis, O.D. Optometrist North BRIEF STATEMENT 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 specified MR environment under specified conditions, please see label for details. PRECAUTIONS The surgeon should monitor the patient postoperatively 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 significant prior trauma, chronic inflammation, 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 significant 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 opacification (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.