Hannover, Germany, December 03, 2018 / B3C newswire / -- Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) announced today 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.
Max Ostermeier, CEO of Implandata commented: “The successful inclusion of the first ARGOS-SC01 study patient is a pivotal milestone for Implandata towards broadening the use of our EYEMATE system, eventually allowing also stand-alone implantation of our proprietary eye pressure sensing devices.”
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.
Intraocular pressure monitoring is a considerable challenge for glaucoma patients and their ophthalmologists. Current IOP measurement methods require in-office procedures to be performed by trained medical staff. However, these measurements are obtained just a few times a year, although it is known that the eye pressure is highly dynamic and influenced by many parameters and, thus, changing throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP measurements throughout 24 hours and outside the ophthalmologist’s office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients. As the EYEMATE system provides direct feedback to the patient in a home setting - information previously unavailable to the patient - therapy compliance will be improved, as it was already observed in earlier studies. Additionally, EYEMATE’s remote patient care capabilities will result in more efficient disease management, as number of office visits may be reduced for a considerable number of patients, while the eye doctor attains more and better information about the patient’s specific situation. Lastly, the aggregation of IOP measurement data may shed new light on the emergence and progression patterns of the disease, potentially unlocking new or more efficacious intervention approaches.
Glaucoma is a chronic eye disease and a leading cause for irreversible vision loss worldwide. Intraocular pressure is the only modifiable risk factor to reduce the peril of vision loss. Reduction and control of eye pressure in glaucoma patients limits the risk of disease progression considerably (1). Close to 80 million patients are affected by the disease globally; further, due to aging populations, the number of patients is expected to increase to 112 million by 2040 (2). Implandata is addressing a pressing need in a continuously growing market with its products for improved glaucoma care.
Implandata is a privately-held, ISO 13485-certified medical device company, which was founded in 2010 in Hannover, Germany. With the CE-marked EYEMATE-IO device, Implandata has developed the world’s first implantable, permanent IOP pressure sensor for direct measurement and continual monitoring of eye pressure in glaucoma patients. The EYEMATE system is complemented by a patient device for automated intraocular pressure data acquisition and real time data-provision to the eye care specialists.
Implandata Ophthalmic Products GmbH
Max G. Ostermeier
Phone: +49 551 2204 2581
Fax: +49 511 2204 2589
(1) „Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial; Heijl et al, 2002
(2) “Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040”; Tham et al, 2014
Posted by Sabine Duntze, B3C Group GmbH and shared through Newronic®