Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Budget101 Discussion List Archives Recalls Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

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      budget

      Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the compass-xt long-term safety study.

      the us food and drug administration (fda) approved the cypass micro-stent in july 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year compass study. the compass study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the cypass micro-stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone. at two years post-surgery, there was little difference in endothelial cell loss between the cypass micro-stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.1, 2

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Budget101 Discussion List Archives Recalls Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma