The first brain-computer interface (BCI) device for vision restoration – Prima – has been commercially launched in Europe with the first commercial implant expected in Germany soon.
Prima has received a CE (Conformité Européenne) mark, authorising its commercial availability across 30 European countries. Papers recently published by the New England Journal of Medicine1 showed that Prima restored vision to patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD).
Prima is designed to use a tiny implant and special pair of glasses to replicate the function of light-sensitive cells in the eye that have been lost.
“We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision,” said Max Hodak, CEO and co-founder of neural engineering company Science Corporation.
“For decades, losing central vision to this disease meant losing the ability to read, recognise faces, and ultimately losing independence. There was no viable treatment. Now there is,” he said.
“We intend to make access to Prima real and reimbursable, as quickly as possible.”
In the United States, Prima has received Food and Drug Administration ‘Breakthrough Device’ designation and ‘Humanitarian Use Device’ designation.
In Australia, the Save Sight Institute and the Sydney Eye Hospital recently launched a clinical trial to test the effectiveness of the new device, which partially restores vision through the electrical stimulation of the retina.
Under the leadership of Professor Matthew Simunovic, head of the Save Sight Institute’s Retinal Disease and Rescue Group, a three-year clinical trial called PRIMAlia, testing the effectiveness and safety of the Prima system, has been launched. PRIMAlia is the first study of its kind for inherited retinal diseases.
For more details on the clinical trial for patients with Stargardt disease or retinitis pigmentosa, contact Clinical Research Orthoptist Catherine Le at catherine.le@sydney.edu.au.
References available at mivision.com.au.