Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) announced yesterday that the first patient in its international, multi-center, ARGOS-SC01 clinical study has been successfully implanted with its novel pressure sensor. This first-in-human clinical study is being conducted to validate the suprachoroidally-placed EYEMATE-SC sensor implant for continual monitoring of intraocular pressure (IOP).
Principal Investigator, Prof. Peter Szurman of the Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Germany who performed the implantation of the EYEMATE-SC device in conjunction with non-penetrating glaucoma surgery stated: “The new Implandata sensor is pleasantly small and easy to surgically implant; therefore, most patients undergoing glaucoma surgery are likely to be eligible candidates for such a pressure sensor. This breakthrough product enables glaucoma patients for the first time to monitor their own eye pressure at any point in time. I expect that it will improve therapeutic compliance and also significantly reduce the risk of unnecessary visual field loss or even blindness due to glaucoma.”
While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use in glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation in glaucoma patients not indicated for cataract surgery yet, thus complementing Implandata’s product offering and expanding the indication of use of the EYEMATE-system.
Implandata is currently expanding its ARGOS-SC01 study by including the Ophthalmic Clinic of Ruhr-University Bochum (Germany), the Department of Ophthalmology at University Mainz (Germany), and the Montchoisi Clinique Lausanne (Switzerland). The study will be closely monitored by an independent Data Safety Monitoring Board, chaired by Professor Emeritus Günter Krieglstein – the former Director of Department of Ophthalmology of Medical University Cologne, Germany, and a world-renowned glaucoma expert. The completion of the study is expected by early 2020.
Read the full news release.