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

Glaukos received European Union (EU) Medical Device Regulation (MDR) certification for iStent infinite, along with several of its other MIGS technologies, including iStent inject W.

Glaukos received FDA 510(k) clearance for the iStent infinite Trabecular Micro-Bypass System in 2022. The iStent infinite is indicated for use in a standalone procedure to reduce elevated IOP in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy. The iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately 6 clock hours around Schlemm’s canal. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. 

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

"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,” Thomas Burns, Glaukos chairman and chief executive officer, said in a company news release. “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."

According to Glaukos, these certifications affirm that iStent infinite and iStent inject W meet the stringent requirements of the EU MDR—a new framework established to ensure high standards of quality, safety and effectiveness for medical devices marketed in the EU.