Glaukos has secured European Union Medical Device Regulation (EU-MDR) certification for its iStent infinite, along with other micro-invasive glaucoma surgery (MIGS) technologies, including the iStent inject W.
According to the company, its iStent trabecular micro-bypass stenting platform predominantly involves the insertion of micro-scale surgical devices intended to minimise intraocular pressure (IOP) with the restoration of pathways of the natural aqueous humor outflow for individuals with glaucoma.
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Known for creating two patent bypass pathways via the trabecular meshwork, the iStent inject W claims to be one of the smallest medical devices to be implanted in the body of a human.
Its design allows for multi-directional flow through Schlemm’s canal, offering a micro-invasive approach to glaucoma treatment.
The iStent infinite Trabecular Micro-Bypass System Model iS3 is intended to minimise IOP in adults with primary open-angle glaucoma where prior treatments have failed.
As the first standalone micro-invasive implantable alternative, the iStent infinite is said to have been tailored to maximise outflow with minimal disruption to natural anatomy, occupying 3% of Schlemm’s canal.
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By GlobalDataGlaukos CEO and chairman Thomas Burns said: “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.”
Last year, the company began commercial launch activities for iDose TR, an intracameral procedural pharmaceutical that provides continuous glaucoma drug therapy inside the eye for extended periods.
In 2023, speciality materials and chemical company Celanese entered an agreement with Glaukos for the supply of its VitalDose drug delivery platform.
