Glaukos Secures EU MDR Certification for iStent infinite and iStent inject W

Glaukos has announced that it has received the European Union (EU) Medical Device Regulation (MDR) certification for its iStent infinite, along with several of its other micro-invasive glaucoma surgery (MIGS) technologies, including the iStent inject W.

Regulatory Progress in the EU and US

The iStent infinite previously received FDA 510(k) clearance in 2022. It is indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma that remains uncontrolled despite prior medical and surgical therapy.

About the iStent infinite and iStent inject W Systems

The iStent infinite system includes three heparin-coated titanium stents, preloaded into an auto-injection system that enables the surgeon to place stents across approximately 6 clock hours around Schlemm’s canal. Once implanted, these stents are designed to lower IOP by restoring the eye’s natural physiological outflow of aqueous humor.

This mechanism of action is similar to the company’s two-stent iStent inject W Trabecular Micro-Bypass System, which is already approved in both the US and EU. The iStent inject W is indicated for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma undergoing concomitant cataract surgery.

Company Perspective and Strategic Outlook

Thomas Burns, Glaukos chairman and chief executive officer, commented on the significance of these certifications in a company news release. He stated, “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. 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."

Meeting the Stringent EU MDR Standards

According to Glaukos, the certifications confirm that both the iStent infinite and the iStent inject W meet the rigorous requirements of the EU MDR, a recently established framework designed to ensure high standards of quality, safety, and effectiveness for all medical devices marketed within the European Union.