[Nfbf-l] Alpha IMS Becomes Second Bionic Retina Approved in Europe

[Alan Dicey]

Foundation Fighting Blindness - Alpha IMS Becomes Second Bionic Retina 
Approved in Europe
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?"