Glaukos announced it received EU MDR certification for its iStent Infinite, along with several other technologies.
Aliso Viejo, California-based Glaukos can now bring iStent Infinite and iStent Inject W to the European market. The micro-invasive glaucoma surgery (MIGS) technologies feature a trabecular micro-bypass stenting platform. They utilise the insertion of micro-scale surgical devices designed to reduce intraocular pressure.
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Glaukos designed its devices to restore the natural aqueous humor outflow pathways for patients suffering from Glaucoma.
iStent’s indication covers adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. Glaukos believes it offers the industry’s “most comprehensive offering of minimally invasive, tissue-sparing glaucoma solutions.”
The ophthalmic pharmaceutical and medical technology company develops therapies for a number of chronic eye diseases. Its offerings extend to therapies for corneal disorders and retinal diseases.
“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 chair 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.”
