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    Glaucoma monitoring implant receives CE mark

    An implantable glaucoma sensor has received CE mark approval for marketing in the European Union.

    The sensor (Eyemate, Implandata Ophthalmic Products) can provide frequent IOP readings, informing patients and their physicians about how the pressure changes by time of day and from one day to another.

    Professor Hagen Thieme of Otto-von-Guericke University Magdeburg in Germany led the pivotal ARGOS-02 trial used to obtain CE mark certification. Implandata spokesperson Max Ostermeier declined to disclose results of that trial pending publication, but noted that Implandata had redesigned the implant based on results of the pilot ARGOS-01 study.

    For that study, the ring-shaped sensor consisted of eight pressure-sensitive capacitors in a single application-specific integrated circuit combined with a circular microcoil antenna, all encapsulated in silicone.

    The device measured 11.2 mm in diameter and 0.9 mm in thickness. A hand-held device transmitted energy to the sensor telemetrically and received and stored its data. The Global System for Mobile communication module allowed transfer of the data to a database that physicians could access online.

    The company, based in Hannover, Germany, is developing a smart ‘phone application allowing the patient to track this data and communicate with the physician.

    The device offers advantages over current methods for IOP monitoring, according to Implandata. Because conventional monitoring requires visits to the offices of trained healthcare workers, these measurements are obtained just a few times each year, even though IOP may fluctuate throughout the day.

    Measuring IOP throughout the day, every day, could allow patients and their physicians to tailor glaucoma medications to the patients’ specific needs, Implandata said.

    "Twenty-four hour monitoring of intraocular pressure with an implantable sensor is transformative for management of glaucoma patients as it provides a plethora of data and deeper insight for enhanced management of their disease,” said Implandata’s Scientific Advisor Dr Robert N Weinreb, director of the Shiley Eye Institute of the University of California, San Diego, in the press release.

    The newly designed implant avoids adverse events seen with the ARGOS-1 trial, Ostermeier said.

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