July 5, 2013 – The Alpha IMS, a subretinal implant developed by Retina Implant AG of Reutlingen, Germany, has been granted European marketing approval. The device received a CE Mark, a regulatory designation for meeting European safety and reliability standards. Also known as an artificial or bionic retina, the Alpha IMS has restored some vision in people who were virtually blind from advanced retinitis pigmentosa (RP). Additional information on the device’s availability is forthcoming from Retina Implant AG.
The Alpha IMS has been in European clinical trials since 2005. Thirty-six people have received the device with some reporting meaningful vision restoration, including the ability to read signs and recognize objects. Retina Implant AG is planning to launch clinical trials of the Alpha IMS in the United States.
The device is a 3x3 mm2 microchip with 1,500 electrodes. It’s placed underneath the fovea, a central point in the retina responsible for the vision most critical to a person’s independence and ability to perform everyday tasks. The Alpha IMS microchip contains a tiny camera, so no external camera or video device is required. The device communicates wirelessly to an external coil, placed behind the ear, which connects to a power supply controlled by the patient.
“We are very excited about European marketing approval for the Alpha IMS. People with advanced RP have few options for restoring some vision to improve their independence and quality of life,” says Stephen Rose, Ph.D., chief research officer of the Foundation Fighting Blindness. “European marketing approval for the Alpha IMS is an important milestone in the advancement of artificial retina technologies.”
The Alpha IMS is the second artificial retina to receive European marketing approval. The Argus II, a retinal prosthesis system developed by Second Sight Medical Products, received the CE Mark in 2011. In February 2013, the Argus II received marketing approval from the U.S. Food and Drug Administration.
To learn more about the field of bionic retinas, visit Dr. Rose’s recent Eye on the Cure blog post titled “The Argus II is Approved: What’s Next for Bionic Retinas?”