Second Sight's retinal prosthesis system approved for reimbursement in France

2 April 2014

Second Sight Medical Products has announced that its Argus II Retinal Prosthesis System has become the first recipient of the French Government's 'Forfait Innovation' programme for reimbursement of innovative treatments.

Argus II is the world’s first approved device intended to restore some functional vision for people suffering from blindness due to outer retinal degenerations.

The Forfait Innovation Award is a new funding mechanism launched by the Ministry of Social Affairs and Health to fast track the provision of innovative healthcare technologies to French patients.

The Forfait Innovation funding covers the costs of implantation of Argus II and includes patients’ hospital fees. With funding in place, a long-awaited official program to treat advanced retinitis pigmentosa (RP) is commencing in France. Up to 30 patients per year in France now stand to benefit from this life-changing technology.

The Argus II System works by converting video images captured by a miniature 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 surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function.

According to a study published in the British Journal of Ophthalmology  the majority of blind subjects fitted with the Argus II consistently identify letters and words using the retinal implant, indicating reproducible spatial resolution. This, in combination with the proven, stable, long-term function of the device, represents significant progress in the evolution of artificial sight.

Professor Jose-Alain Sahel, professor of Ophtalmology, University Pierre et Marie Curie, head of department, Quinze-Vingts Hospital, director of the Vision Institute (UPMC/INSERM/CNRS), said of this decision: “We have been involved in the development of this product for more than five years. This announcement is hugely significant for us and for French patients blinded by retinal diseases. These patients face a great unmet medical need, as there are no current solutions to improve their vision. Additionally, the announcement provides encouragement for other solutions currently under development at Vision Institute in Paris, to further ameliorate conditions resulting in blindness.”

Gregoire Cosendai, Second Sight’s vice president, Europe, said: “We salute the decision of Marisol Touraine, Minister of Social Affairs and Health following a thorough health technology assessment conducted by the team at the Haute Autorite de Sante who determined that this innovative solution for restoring vision was worthy of reimbursement in France. It is tremendous news for several patients in France who have been blind for some time and are awaiting a treatment to improve their vision and quality of life. It’s also a great tribute to the excellence of the Quinze-Vingts Hospital who participated in the multicenter clinical trial that lead to the first market approval of the Argus II retinal prosthesis in Europe and the USA.”

In the UK, the National Health Service is currently considering reimbursement for the device. After commercial launch in Europe in 2011, Second Sight announced in January of this year (2014) that the first US patients have been implanted following FDA approval last year (2013).

Source: Second Sight


To top