Implandata Ophthalmic Products reported that its next-generation Eyemate micro-sensor implant for intraocular placement has successfully passed first-in-human validation.
“This opens up the path to proceed forward towards design finalization, expanded clinical validation and regulatory approval. Eventually this will further increase the use of the Eyemate system," Max Ostermeier, CEO of Implandata, said in a company news release.
Successful in-human validation of the miniaturized next-generation Eyemate micro-sensor implant represents another pivotal milestone for Implandata. While the current sensor implant requires a surgical incision size of at least 4 mm, the next generation Eyemate micro-sensor device reduces incision size for implantation down to 2.7 mm and less.
“Reduction of incision size is one major advancement, easier insertion and positioning of the micro-sensor another benefit. In eye surgery, less invasive methods mean lower risk of surgical or post-surgical complications, resulting in higher surgeons’ acceptance, also by less experienced ophthalmic surgeons," Prof. Burkhard Dick, Director of the University Eye Hospital of Bochum/Germany who carried out the first-in-human validation, said in the news release.
The Eyemate system provides actionable IOP readings throughout the day and outside the eye care specialist office, enhancing treatment options and reducing progressive vision loss in glaucoma patients. In addition, as the Eyemate system provides direct feedback to the patient in a home setting - information previously unavailable to the patient - therapy adherence will be improved, as demonstrated in premarket studies, according to Implandata.
The Eyemate system includes a surgically implantable micro-sensor (to be implanted in conjunction with cataract, glaucoma or corneal surgery, ultimately also in a stand-alone procedure) for direct measurement of eye pressure. A patient hand-held device for sensor implant powering and data read-out is communicating real-time via internet with eye care specialists (and the patient as well). Most recently published long-term patient follow-up data confirmed product safety and utility.In June 2017, Implandata’s Eyemate system for enhanced monitoring and management of glaucoma patients received European CE mark approval with its current micro-sensor implant. A first European market launch of this product is planned for 2018.