Retina Implant secures CE mark for wireless subretinal implant

CE certification enables commercialization of Alpha AMS device to restore some useful vision in patients blinded by retinitis pigmentosa.

Retina Implant, the developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), announced it received CE approval of its Alpha AMS device for marketing in the European economic area.

The Alpha AMS, which is the next generation of the Alpha IMS (CE marked in 2013), is designed to restore some useful vision in patients blinded by the degenerative eye condition and has been in clinical trials across Germany and the UK since 2014. The technology has an increased number of pixels (1600), giving it the most electrodes of any neuroprosthetic implant on the market, and is estimated to last several years in the body.

We are delighted by the news that our latest device has received the CE mark. We believe that being able to provide physicians access to the Alpha AMS represents a notable step forward in treatment options for their patients,” said Walter-G Wrobel, Ph.D, CEO of Retina Implant AG. “We look forward to making our technology commercially available to the patient community across Europe. We would also like to thank those patients who participated in the clinical trials to date – they have been critical to the success of our research and evolution of the Alpha AMS.”