For more information on CyPass® Ultra System, visit www.getcypass.com
Arsham Sheybani, MD, explains why the introduction of new microinvasive glaucoma surgery (MIGS) devices like CyPass® Micro-Stent (Alcon) make it an exciting time to be a glaucoma surgeon. Watch as he describes how the innovative CyPass® Ultra System streamlines surgery and helps surgeons improve the efficiency of this MIGS procedure.
Physician is a paid consultant of Alcon
Paid consultants of Alcon
Paid consultant of Alcon
CYPASS® ULTRA SYSTEM Important Product Information
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indication: The CYPASS® Ultra System 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® Ultra System is contraindicated 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 anomalies of the anterior chamber angle.
MRI Information: The CYPASS® Micro-Stent is magnetic resonance (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 resonance 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 improper 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® Ultra System has not been established 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 associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucomas, eyes that have undergone prior incisional glaucoma 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 iatrogenic 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 randomized, multicenter clinical trial comparing cataract surgery with the CYPASS® Micro-Stent to cataract surgery alone, the most common post-operative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for CYPASS® vs. 15.3% for cataract surgery only); anterior 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 contraindications, warnings, precautions and adverse events.
One CyPass® Micro-Stent is all it takes to deliver on the promise of MIGSLEARN MORE
The CyPass® Micro-Stent System
for the Treatment of Primary
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