An implant designed to restore a degree of sight to people with advanced retinal degenerative diseases has been approved for sale in the European Economic Area (EEA).
The Argus II Retinal Prosthesis System was developed by Second Sight Medical Products, a US company whose European headquarters are in Lausanne, Switzerland.
After a clinical trial involving more than 30 blind patients, and a review of the product’s safety and performance by an independent expert body, the device is said to be the first approved treatment ever available for sightless people.
‘After years of research, we are… able to offer a viable long-term solution for people suffering from advanced retinal degenerative diseases such as retinitis pigmentosa [RP],’ said Robert Greenberg, managing director, president and chief executive officer of Second Sight. ‘The CE Mark approval… represents a huge step forward for the field and for these patients who have, until now, had no proven treatment alternatives.’
Argus II is Second Sight’s second-generation implantable device intended to treat profoundly blind people suffering from degenerative diseases such as RP.
Second Sight said in a statement that the system converts video images captured from a camera — housed in the patient’s glasses — into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the retina.
These pulses then stimulate the retina’s remaining cells, resulting in the corresponding perception of patterns of light in the brain. Patients learn to interpret these visual patterns and, in doing so, gain a degree of functional vision.
‘The fact that nearly all patients had a stable, safe and functioning system, and that a majority of patients could recognise large letters and locate the position of objects, and the best could read short words, impressed us beyond our most optimistic expectations,’ said Dr Lyndon da Cruz, a consultant retinal surgeon at Moorfields Eye Hospital, London.
With CE Mark approval, the Argus II is planned to be available later this year in clinical centres, including Manchester Royal Eye Hospital and Moorfields Eye Hospital.