Ophthalmology Management Supplements September

Glaucoma Physician Sep 2017

Issue link: https://ophthalmologymanagementsupplements.epubxp.com/i/870233

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A NEW ERA IN THE SURGICAL TREATMENT OF REFRACTORY GLAUCOMA - The first ab-interno approach to create a new pathway for aqueous flow from the anterior chamber to the subconjunctival space 1-3 - Minimally invasive—a 6-mm gel stent designed to be implanted through a small corneal incision 1 - Established effectiveness and safety 1 WELCOME TO GENERATION XEN ® 1. XEN ® Directions for Use. 2. CyPass ® Directions for Use. 3. iStent ® Directions for Use. INDICATIONS The XEN ® Glaucoma Treatment System (XEN ® 45 Gel Stent preloaded into a XEN ® Injector) is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS XEN ® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber IOL, intraocular silicone oil, and vitreous in the anterior chamber. WARNINGS XEN ® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN ® Gel Stent to avoid the potential for implant damage. PRECAUTIONS Examine the XEN ® Gel Stent and XEN ® Injector in the operating room prior to use. Monitor IOP postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN ® system. Safety and effectiveness of more than a single implanted XEN ® Gel Stent has not been studied. ADVERSE EVENTS The most common postoperative adverse events included BCVA loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%). Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit allergan.com or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event. Minimally Invasive. Powerfully Effective. 1 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. XenGelStent.com XEN103680 01/17 162958

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