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Reflecting its uncompromising commitment to patient safety, Alcon now announced a direct, voluntary market withdrawal of their CyPass Micro-Stent in the worldwide industry. Additionally, Alcon advises surgeons to quickly cease additional implantation using the CyPass Micro-Stent and to return any unused devices to Alcon. This conclusion and corresponding recommendation is based on an investigation of post-surgery data in the COMPASS-XT long-term security analysis.
The US Food and Drug Administration (FDA) accepted the CyPass Micro-Stent at July 2016 for use in combination with cataract surgery in older patients using mild-to-moderate main open-angle glaucoma dependent on the outcomes of the landmark two-year COMPASS research. The COMPASS study revealed a statistically significant decrease in intraocular pressure at a couple of years post-surgery in areas implanted with the CyPass Micro-Stent in the time of cataract surgery, in comparison with areas undergoing cataract surgery alone. At two years post-surgery, there was little difference in endothelial cell loss involving the CyPass Micro-Stent and Illness surgery-only groups, and outcomes were consistent with peer-review literature benchmarks of cataract-related endothelial cell reduction.1, 2
