German devicemaker Implandata has successfully completed the ARGOS-01 pilot study evaluating the safety and functionality of its implantable intraocular pressure sensor, the company announced Friday.
The first-in-human clinical trial followed six glaucoma patients at University Eye Clinic in Aachen, Germany, for one year and showed that Implandata’s implant is safe and effective, the company says.
The implant consists of a microsensor that is smaller than a U.S penny and can detect intraocular pressure data, along with a handheld device that transfers energy to the sensor and reads and stores the data that the sensor transmits. According to Implandata, it shows “excellent measurement accuracy and long-term stability,” allowing pressure to be measured at any cycle, frequency of repeatability without disruption of daily activities. The device can also transmit pressure fluctuation and variability information to the patient’s doctor, which aids in the evaluation of efficacy of treatment, the company says.
Implandata is preparing a second, larger study, called ARGOS-02, to support an application for CE marking. — Lena Freund
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