CE Mark For Implandata's EYEMATE System For Improved Monitoring And Management Of Glaucoma Patients
Hannover, Germany, May 31, 2017 / B3C newswire / -- Implandata’s EYEMATE system for enhanced monitoring and care of glaucoma patients has attained CE certification and is available for commercial use within the EU. The system was developed and is produced by Implandata Ophthalmic Products GmbH (Implandata), an emerging Hannover/Germany based ophthalmic device company.
Intraocular pressure (IOP = eye pressure) control is a key challenge for glaucoma patients. Current methods for IOP control require in-office measurements that are performed by trained medical staff. However, these measurements are obtained just a few times each year, even though the eye pressure is known to change throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP readings throughout the day and also day to day. Such information is not obtainable with any other method. Having IOP measurements throughout the 24 hour day and also every day, provides information that will enhance treatment and reduce progressive vision loss in glaucoma patients.
The EYEMATE system includes a permanent implantable micro-sensor (to be implanted during cataract, glaucoma or corneal surgeries, ultimately also in a stand-alone procedure) for direct measurement of eye pressure. A patient hand-held device for sensor powering and data read-out is communicating real-time via internet with eye care doctors (or the patient as well). These measurements can be obtained conveniently at home or at work, and there is no need for the patient to have the measurements at their doctor’s office.
Patients can take eye pressure readings themselves easily and at any chosen frequency under normal life conditions. Instead of just a few IOP measurements per year, the system can provide numerous ones throughout the day and day after day. With such information, glaucoma medications can be tailored to the patient’s specific need. As the EYEMATE system also provides a direct feedback to the patient in a home setting - information previously unavailable with standard methods - patient therapy adherence is improved, as demonstrated in pre-market studies.
Professor Hagen Thieme, Director of the Ophthalmology Department of the Otto-von-Guericke University Magdeburg and principal investigator of the pivotal ARGOS-02 trial, that lead to the CE mark, summarized the clinical experience obtained during the trial “Based on our clinical experience with the EYEMATE system it can be well handled by the ophthalmic surgeon. The device can be safely implanted in the sulcus during normal cataract surgery and has proven to be highly beneficial for both the clinician as well as the patient. I firmly believe that the EYEMATE system will open up new horizons towards our clinical and scientific understanding of intraocular pressure and help us to advance our treatments towards individualized and better glaucoma care.”
The current EYEMATE system version is CE marked for use with primary open angle glaucoma patients. Implandata is also working on other versions to be used in other glaucoma situations.
Professor Robert N. Weinreb, Director of the Shiley Eye Institute of University San Diego, California, USA and Implandata’s Scientific Advisor comments "24 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.”
Glaucoma is a chronic eye disease and worldwide the leading cause for irreversible vision loss. Reduction and control of IOP demonstrated to be the only effective treatment to reduce the risk of disease progression. Globally close to 80 million patients are affected by the disease now; by 2040 then number is expected to increase because of the aging population and life-style to 112 million patients worldwide(1). With its products for improved glaucoma management, Implandata is addressing a pressing need in a global, further growing market.
About Implandata Ophthalmic Products GmbH
Implandata Ophthalmic Products GmbH is a privately held, ISO 13485 certified medical device company founded in 2010 in Hannover/Germany. Implandata’s product for continuous monitoring of intraocular pressure and e-Health is providing vastly improved quality and quantity of intraocular pressure data, which is key for personalized care and therapy control. Remote patient management will increase glaucoma treatment efficiency and will contribute to cost savings for all stakeholders.