FEB 2019

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: http://digital.eyeworld.org/i/1075962

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Page 85 of 86

INDICATION FOR USE. The iStent inject ® Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure ( IOP) in adult patients with mild to moderate primary wopen-angle glaucoma. CONTRAINDICATIONS. The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or 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 of the angle that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent inject is MR-Conditional, i.e., the device is safe for use in a specifi ed MR environment under specifi ed conditions; please see Directions for Use ( DFU ) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with signifi cant prior trauma, abnormal anterior segment, chronic infl ammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. ADVERSE EVENTS. Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction ( 6.2%), intraocular infl ammation ( 5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention ( 5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%). 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. REFERENCES: 1. iStent inject ® Trabecular Micro-Bypass System: Directions for Use, Part #45-0176. 2. Hengerer FH. Personal experience with second-generation trabecular micro-bypass stents in combination with cataract surgery in patients with glaucoma: 3-year follow-up. ASCRS 2018 Presentation. © 2018 Glaukos Corporation. Glaukos and iStent inject are registered trademarks of Glaukos Corporation. PM-US-0026 Optimized Outfl ow: Two multi-directional stents designed to restore natural outfl ow Clinically Proven: Signifi cant IOP reduction across a wide range of clinical studies 1,2 Procedural Elegance: Predictability and precision to meet the needs of your practice Proven Safety: Safety profi le similar to cataract surgery alone 1 TRANSFORMING MIGS IN MORE WAYS THAN ONE. TransformMIGS.com | 800.GLAUKOS (452.8567) All with the exceptional customer support you've come to expect from Glaukos.

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