Glaukos Corporation Announces European Union Medical Device Regulation Certification for iStent infinite® and Other Leading MIGS Therapies

Published: 2025-06-25 17:20:30 ET GKOS

Published on 06/25/2025 at 17:20

Glaukos Corporation announced it has received European Union (EU) Medical Device Regulation (MDR) certification for iStent infinite, along with several of its other leading micro-invasive glaucoma surgery (MIGS) technologies, including iStent inject W. Glaukos? iStent trabecular micro-bypass stenting platform primarily involves the insertion of a micro-scale surgical devices designed to reduce intraocular pressure by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma. These certifications affirm that iStent infinite and iStent inject W meet the stringent requirements of the EU MDR ?

a new, robust framework established to ensure high standards of quality, safety and effectiveness for medical devices marketed in the EU. Glaukos is proud to be the corporate pioneer and global market leader in MIGS, with its family of iStent technologies supported by nearly 400 peer-reviewed publications, 20 plus years of clinical and commercial experience and more than one million iStent devices implanted worldwide since its inception. The company believes it offers the industry?s most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting its goal to provide a full range of options to fit surgeons?

individual glaucoma treatment algorithms that offer the most favorable short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures.