Glaukos Corporation, a company specializing in eye care therapies for glaucoma, corneal disorders, and retinal diseases, has received European Union (EU) Medical Device Regulation (MDR) certification for its iStent infinite device. This approval also includes several other key products from its micro-invasive glaucoma surgery (MIGS) portfolio, such as iStent inject W.

The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma.

“We’re pleased to receive these important approvals under the new EU MDR framework,” said Thomas Burns, Glaukos Chairman and CEO.

“This marks a major milestone for our company and will help strengthen our position in Europe while supporting our broader global Interventional Glaucoma strategy. We look forward to launching these innovative MIGS treatments in the coming months.”

The EU MDR certification confirms that iStent infinite and iStent inject W meet the EU’s updated and more rigorous standards for medical device quality, safety, and effectiveness.