Implandata Gains CE Mark for Next-Generation EyeMate System

Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) has attained CE mark for its next-generation EYEMATE-IO 1.1 implantable micro-sensor. The CE-certified product enables eye surgeons to place the permanent implantable eye pressure sensor in conjunction with cataract surgery through significantly smaller incisions. The micro-sensor performs continual monitoring of eye pressure in glaucoma patients, providing highly critical information for guided glaucoma therapy.
 
Prof. med. Burkhard Dick, director of the University Eye Clinic of Knappschaftskrankenhaus Bochum and current president of the German Society for Cataract & Refractive Surgeons, stated, “Implanting the next-generation intraocular micro-sensor is almost a minor intervention in the hands of an experienced surgeon and can be performed during cataract surgery without any major hassle and without increasing the likelihood of complications. From the surgeon’s point of view, this further miniaturization is a major breakthrough and has the potential to render the sensor a valuable and reliable tool for monitoring IOP. Given the relatively high proportion of cataract patients who also suffer from glaucoma, we can expect to implant ever larger numbers of these microsensors in the foreseeable future.”
 
Volker Dockhorn, CEO of Medicel AG, Altenrhein/Switzerland, which is manufacturing the customized ACCUJECT EM-IO 1.1 delivery system for Implandata, explained, “We are delighted to be working with Implandata on this exciting product. The injection of the implantable microsensor EYEMATE-IO 1.1 is one of these exciting challenges that we are happy to face when it comes to injecting new innovative implants into the eye. With the ACCUJECT injector platform specially adapted to the EYEMATE-IO 1.1 sensor, the surgeon can now reduce the required incision size down to less than 3.2 mm.”
 
Intraocular pressure (IOP) 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 the 24 hours period and outside the ophthalmologist’s office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients,” elucidates Implandata’s CEO, Max Ostermeier and continues “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 already observed in earlier studies.”
 
Implandata is currently preparing for an initial market launch of its products at EYEMATE clinical ‘Centers of Excellence’ in Germany and Switzerland in 2019, followed by further internationalization in 2020 and the subsequent years.
 
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. 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. 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.