Alcon issued a global recall of CyPass Micro-Stent and advised surgeons to immediately stop implanting the device in patients after reviewing long-term safety data, Verdict Medical Devices reports.
Here are five insights:
1. Alcon asked surgeons to return any unused devices following an analysis of five-year postsurgery data. The recall applies to all CyPass Micro-Stent versions.
2. CyPass Micro-Stent is a micro-invasive glaucoma surgical device indicated for adults with mild-to-moderate primary open-angle glaucoma who undergo cataract surgery.
3. The FDA approved CyPass Micro-Stent in July 2016 based on two-year study results showing a statistically significant reduction in intraocular pressure in patients with the implant. The study also compared patients with and without the device and found no significant difference in endothelial cell loss two years after surgery.
4. However, at five years post-surgery, endothelial cell loss was statistically significant in patients with the device, the recent analysis revealed.
5. Alcon, a Novartis subsidiary, plans to give ophthalmic surgeons guidance on evaluating and managing patients 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 labelling changes that would support the reintroduction of the CyPass Micro-Stent in the future," said Alcon CMO Stephen Lane.