After analyzing the five-year follow-up data from the COMPASS-XT long-term safety study, Alcon has announced an immediate, voluntary withdrawal of the CyPass Micro-Stent.
The study, designed to follow patients from the original COMPASS trial for another three years, found those who had CyPass Micro-Stent implantation in conjunction with cataract surgery experienced statistically significant endothelial cell loss compared with those who underwent cataract surgery alone.
Not only has the stent been removed from the market, the company has advised surgeons to cease implanting the device and return any unused products to the company.
CyPass Micro-Stent was FDA approved in July of 2016 after two-year COMPASS study results showed a statistically significant reduction in intraocular pressure and little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups.
“We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do,” said Stephen Lane, MD, chief medical officer at Alcon in a statement. “Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future.”
|Alcon. Alcon announces voluntary global market withdrawal of CyPass Micro-Stent for surgical glaucoma. www.alcon.com/news/media-releases/alcon-announces-voluntary-global-market-withdrawal-cypass-micro-stent-surgical. August 29, 2018.|