Glaukos Earns EU Nod for iStent Glaucoma Surgery Tech

Glaukos has received EU MDR certification for iStent infinite, as well as other micro-invasive glaucoma surgery (MIGS) tech including iStent infinite and iStent inject W.

The iStent trabecular micro-bypass stenting platform involves insertion of a micro-scale surgical devices to reduce intraocular pressure. It does so by restoring the natural aqueous humor outflow pathways for glaucoma patients.

The certifications affirm that iStent infinite and iStent inject W meet the EU MDR’s stringent requirements. The EU MDR is a new, robust framework to ensure high standards of quality, safety, and effectiveness for medical devices marketed in the EU.

“We are pleased to receive these important regulatory clearances for our leading trabecular micro-bypass stenting devices, marking our company’s first approvals under the new EU regulatory framework,” said Thomas Burns, Glaukos chairman and CEO. “These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally. We are eager to commence commercial launch activities for these novel MIGS therapies over the coming months.”

iStent technologies are supported by almost 400 peer-reviewed publications, over 20 years of clinical and commercial experience, and more than a million devices implanted globally since its inception.

In March, the company teamed up with Topcon Healthcare and RadiusXR to expand access to and help doctors provide visual field exams and glaucoma test eduction.