This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: CyPass® System Model 241-S
PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, TX 76134-2099
Approval Date: July 29, 2016
Approval Letter: Not Yet Available
What is it? The CyPass® Micro-Stent is a tiny tube that is implanted into the eye to help drain fluid that builds up in patients with glaucoma. The CyPass® System consists of a small stent (CyPass® Micro-Stent) that is pre-loaded into a stent delivery tool (CyPass® Applier).
How does it work? The CyPass® Micro-Stent is designed to control eye pressure (intraocular pressure, or IOP) by creating a drainage pathway from the inside (anterior chamber) to the outermost layer of the eye (suprachoroidal space).
When is it used? The CyPass® Micro-Stent is used in patients with primary open angle glaucoma (POAG). If not treated, pressure builds up inside the eye and eventually can damage the optic nerve, causing blindness. The CyPass® Micro-Stent is placed in the eye at the time of cataract surgery.
What will it accomplish? Data supporting the approval of this device included 374 subjects implanted with the CyPass® Micro-Stent device at the same time as cataract surgery, and 131 patients that had cataract surgery alone. In this study, 72.5 percent of patients who received the CyPass® Micro-Stent achieved a significant lowering of their IOP compared to 58 percent of patients who had cataract surgery alone. The lower IOP lasted through the 2-year-long study. Complications occurred in 39.3 percent of patients with CyPass® Micro-Stent and cataract surgery and in 35.9 percent of patients with cataract surgery alone.
When should it not be used? The CyPass® Micro-Stent should not be used if:
- patients have a type of glaucoma other than POAG.
- eye anatomy or condition is unusual.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling will be available online. (Not Yet Available)