Implandata Ophthalmic Products said today it won CE Mark approval in the European Union for its Eyemate system intended for use in patients undergoing keratoprosthetsis surgery.
The Eyemate device is designed to allow ophthalmologists to detect increase intraocular pressure so they can better manage patients’ conditions to reduce the risk of post-surgical complications and vision loss, the Hannover, Germany-based company said.
The Eyemate platform consists of a pressure sensor designed to be implanted into patients in conjunction with a keratoprosthesis procedure to allow for continual eye pressure monitoring, allowing early detection of increases, the company said.
“Keratoprosthesis surgery is often the last option for these patients to see again. 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,” principal study investigator Dr. Claus Cursiefen of Germany’s Eye Center of University Hospital Cologne said in a prepared statement.
Implandata said that it is now offering the Eyemate system to centers performing keratoprosthesis procedures in Europe.
“Though increasing, the number of patients undergoing keratoprosthesis procedure is still rather low, compared to other procedures performed in the eye care field. 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,” CEO Max Ostermeier said in a press release.