The clinical achievements of CyPass Micro-Stent system were evaluated by reading a study of 505 patients with POAG. 374 patients were randomized to the CyPass Micro-stent in combination with cataract surgery, and 131 patients were randomized to cataract surgery alone.
The study reviewed the percentage of patients with at least a 20% reduction in mean diurnal IOP from baseline and adverse events (AEs) for 24 months after implantation. 72.5% achieved a significant lowering of their IOP, compared to 58.0% of patients who had cataract surgery alone.
See here the FDA aprovement.
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