The decision to pull the devices comes off the analysis of five-year post-surgery data from the Compass-XT study of the device, which showed that patients treated with the stent had statistically significant loss of endothelial cells as compared to a control group. Endothelial cells are believed to be vital in maintaining visual functionality.
The company advised surgeons to immediately cease further implantation of the devices and return any unused devices to Alcon, and added that it will be communicating with surgeons with recommendations for evaluating and managing patients who have already been implanted with the device.
“We believe that withdrawing the CyPass micro-stent from the market is in patients’ best interest and is the right thing to do. 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,” chief medical officer Dr. Stephen Lane said in a press release.
Novartis’ Alcon won FDA clearance for the CyPass micro-stent, with indications for reducing intraocular pressure in patients suffering from glaucoma, in July 2016.