CE Mark for retinal implant

Article

The Alpha IMS, a wireless subretinal implant device, has received the CE Mark.

The Alpha IMS, a wireless subretinal implant device, has received the CE Mark.

The implant, developed by Retina Implant, consists of a 3x3 mm2 microchip with 1500 electrodes inserted beneath the retina. This device has been involved in clinical trials globally since 2005 and recently published results from the company's second human clinical trial have revealed that retinal pigmentosa sufferers will be able to recognize faces and read signs on doors when fitted with the Alpha IMS.

Professor Eberhart Zrenner, founding director of the Institute of Ophthalmology Research, Centre for Ophthalmology, University of Tuebingen, Germany, stated, "After more than seven years of rigorous testing in 36 patients, we are pleased to have demonstrated the safety, reliability and tolerability of the Alpha IMS. It was a very rewarding and touching experience to see blind patients regain some vision that helped them to better master the activities of daily life. This is a landmark in our journey to address the needs of the RP patient community which has limited treatment options available."

Dr Walter G. Wrobel, CEO of Retinal Implant, commented, "We are delighted that our subretinal implant has received CE marking, validating the safety and potential benefits of our revolutionary product to patients and physicians. We look forward to working with clinicians across Europe interested in offering their patients a new pathway to regain vision. We also want to thank all of the patients who participated in our clinical trials, as without their contributions, this day would not be possible."

To read

OTEurope's

Q&A with Professor Zrenner please click

here

.

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