Implandata Ophthalmic Products GmbH (Implandata) says it has successfully implanted its EyeMate intraocular pressure (IOP) sensor implant in a first patient in Europe undergoing keratoprosthesis surgery.
The implantation was performed by study principal investigator Prof. Thomas Neuhann, medical directorâ¨and founder of the Laser Eye Center Munich, within the sponsor-initiated ARGOS-KP01 study.
Implandata’s telemetrically powered EyeMate IOP sensor implant allows for non-invasive measurement and monitoring of IOP in keratoprosthesis patients.
In this first implantation, EyeMate was placed in the patient’s eye at the same time the patient underwent the keratoprosthesis implantation. The sensor allows the patient’s IOP to be measured at any chosen frequency, either continuously or on demand at specific times. Patients can perform the measurements themselves, under the conditions of everyday life.
“Elevated IOP is a main issue with keratoprosthesis patients. Approximately two-thirds of these patients already do have glaucoma preoperatively and management of secondary glaucoma remains a major challenge postoperatively,” Prof. Neuhann said. “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.”
The EyeMate is not yet CE marked or FDA approved. In the ongoing ARGOS-KP01 pre-market study, Implandata is seeking to create clinical data to approach the CE conformity process for use of the EyeMate sensor in keratoprosthesis patients. The company also is currently conducting in parallel its ARGOS-02 study, in which the EyeMate is being tested in primary open-angle glaucoma patients undergoing cataract surgery. Implandata said it is planning to conduct additional clinical studies in Europe and North America to validate complementary product versions for broader glaucoma applications.
http://www.implandata.com/Implandata Ophthalmic Products GmbH is a privately held medical device company founded in 2010 and headquartered in Hannover, Germany and Wilmington, DE, USA. For more information, go to Implandata Ophthalmic Products GmbH.