Breakthrough for improved management of glaucoma patients
Munich and Hannover, Germany, March 2, 2015 / B3C newswire / - Implandata Ophthalmic Products GmbH (Implandata) announces the successful implantation of Implandata’s EyeMate intraocular pressure sensor at a first patient in Europe undergoing keratoprosthesis surgery. The implantation was performed by study principal investigator, Prof. Thomas Neuhann, Munich/Germany within sponsor initiated ARGOS-KP01 study.
Professor Neuhann states: “Elevated intraocular pressure (IOP) is a main issue with keratoprosthesis patients, approximately two-thirds of these patients already do have glaucoma pre-operatively and management of secondary glaucoma remains a major challenge post-operatively.” Current IOP measurement methods cannot be applied in these cases. This is a major reason, why keratoprosthesis patients frequently experience visual field loss and eventually may get blind because of undetected and/or insufficiently controlled glaucoma, explains Prof. Neuhann.
With Implandata’s telemetrically powered EyeMate intraocular pressure sensor implant it is for the very first time possible to non-invasively, exactly measure and closely monitor and control IOP in keratoprosthesis patients. This represents a major breakthrough for better care of these patients and will greatly reduce the risk of visual field loss in these patients.
Implandata’s EyeMate intraocular pressure sensor was placed in the patient’s eye at the occasion of the keratoprosthesis implantation. “It was amazingly easy and straightforward to place the implant where it needs to be”, comments Prof. Neuhann. Right after implantation of the micro sensor implant the patient’s IOP can be measured at any chosen frequency, either continuously or on demand at specific times. Patients can perform measurements by themselves and under the conditions of everyday life. “It is a breakthrough to obtain IOP information any time with ease and at a quality, which otherwise would only be available by performing invasive IOP measurements” is Prof. Neuhann convinced.
In the ongoing ARGOS-KP01 pre-market study Implandata will generate clinical data to approach the CE conformity process for use of its EyeMate intraocular sensor implant also at keratoprosthesis patients. At this moment the product is not CE marked or FDA approved yet. The company is currently conducting in parallel its ARGOS-02 study, where the EyeMate intraocular pressure sensor is tested at primary open angle glaucoma patients undergoing cataract surgery. And Implandata is planning to conduct additional clinical studies in Europe and North America in foreseeable future in order to validate complementary product versions for broader glaucoma applications.
About Implandata Ophthalmic Products GmbH
Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010 and headquartered in Hannover, Germany and Wilmington, DE, USA. Implandata’s product for continuous monitoring of intraocular pressure will transform management of glaucoma patients, providing dramatically improved quality and quantity of intraocular pressure data, which is key for personalized therapy and therapy control. Remote patient management will increase glaucoma treatment efficiency and results in cost savings for all stakeholders.
Contact
Implandata Ophthalmic Products GmbH
Max G. Ostermeier
Kokenstrasse 5
30159 Hannover
Phone: +49 551 2204 2581
Fax: +49 511 2204 2589
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