Eyeworld

©2017 Novartis US-CYP-17-E-1507 CyPass Micro-Stent Important Product Information Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indication: The CyPass Mi- cro-Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). Contraindications: Use of the CyPass Micro-Stent is con- traindicated in the following circumstances or conditions: (1) in eyes with angle closure glaucoma; and (2) in eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anom- alies of the anterior chamber angle. MRI Information: The CyPass Micro-Stent is magnetic reso- nance (MR) Safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic reso- nance imaging environments. Warnings: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to im- proper placement of the stent and pose a hazard. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass Mi- cro-Stent has not been estab- lished as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with significant prior trauma, chronic inflammation, eyes with an abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associ- ated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseu- doexfoliative or pigmentary glaucoma, eyes with other secondary open angle glau- comas, eyes that have under- gone prior incisional glauco- ma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed ≤ 3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmHg or greater than 33 mmHg, eyes with medicated IOP greater than 25 mmHg, in the setting of complicated cataract surgery with iatro- genic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually significant cataract. The safety and effectiveness of use of more than a single CyPass Micro-Stent has not been established. Adverse Events: In a ran- domized, multicenter clinical trial comparing cataract sur- gery with CyPass Micro-Stent to cataract surgery alone, the most common post-opera- tive adverse events included: BCVA loss of 10 or more let- ters at 3 months after surgery (8.8% for CyPass vs. 15.3% for cataract surgery only); ante- rior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). Attention: Please refer to the Product Instructions for a complete list of contraindica- tions, warnings, precautions and adverse events.

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