04.29.19

Implandata Gains CE Mark for its Eyemate System for Keratoprosthesis

Source: Implandata

Ophthalmic sensors and digital health company Implandata Ophthalmic Products announced that it attained CE mark for its Eyemate system for use in patients undergoing keratoprosthesis surgery. Keratoprosthesis represents an infrequent yet important procedure for restoring vision. It is performed on patients whose donor cornea transplantation procedure has failed or shows only limited success. Increased IOP in keratoprosthesis patients is a frequent and major post-surgical complication, resulting in failure of the procedure, secondary glaucoma and, consequently, vision loss.

Implandata’s CE-certified and now commercially-available product allows ophthalmologists to detect increased IOP and to better manage the patient’s condition, minimizing the risk of post-surgical complications and associated vision loss, according to a company news release. Keratoprosthesis patients are typically younger individuals, where preservation of vision is extremely important and costly. Implandata’s proprietary Eyemate eye pressure sensor is implanted in such patients in conjunction with the keratoprosthesis procedure, enabling continual monitoring of the eye pressure. With Eyemate, increased IOP can be detected early on and ophthalmologists are able to better manage challenging situations encountered in such patients.

“Keratoprosthesis surgery is often the last option for these patients to see again,” Prof. med. Claus Cursiefen, Director of the Eye Center of University Hospital Cologne (Germany) and President of the German Association of Ophthalmologists (D.O.G), said in a company news release. “Glaucoma is a severe long-term threat to keratoprosthesis surgery success and there is a significant unmet need to precisely measure intraocular pressure in these patients. This was impossible prior to this novel technology from Implandata.”  

Prof. Cursiefen, together with Prof. med. Thomas Neuhann, Munich (Germany), has been the Principal Investigator of the multicenter ARGOS-KP01 clinical study, where safety and performance of the Eyemate system have been demonstrated in keratoprosthesis patients.

“Though increasing, the number of patients undergoing keratoprosthesis procedure is still rather low, compared to other procedures performed in the eye care field,” Implandata’s CEO, Max Ostermeier said in the news release. “Implandata realized that there is a grossly underserved medical need for these patients in order to attain better post-surgical monitoring. Keratoprosthesis is a costly and complex procedure to restore vision in patients. Potentially impairing again their ability to see because of secondary glaucoma or other post-surgical complication is extremely frustrating for ophthalmologists, but especially sad for patients and their families. We are convinced that our Eyemate system will enable eye doctors to better manage these critical patients and support their efforts to preserve vision.”

With the CE mark, Implandata is now making its Eyemate system available to clinical centers performing keratoprosthesis procedures across Europe. Implandata is currently introducing the CE approved Eyemate product for use in primary open angle glaucoma patients in various markets.

 

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