JAN 12, 2015
Health Canada has approved the Argus II Retinal Prosthesis System (Second Sight Medical Products), the first retinal implant for adults with advanced retinitis pigmentosa. The system was approved in the U.S. last year and in Europe in 2011.
The device is intended for patients 25 years or older who have severe to profound retinitis pigmentosa, bare or no light perception, evidence of intact inner layer retina function, and a history of being able to see forms. It has been implanted in more than 100 individuals worldwide.
The Argus II system includes an external video camera, video processing unit and transmitter mounted on a pair of eyeglasses, along with electrodes implanted internally onto the patient's retina. The video processor wirelessly transmits images captured from the camera as a series of electrical pulses to the electrodes, stimulating retinal cells to produce images.
While vision is not restored, patients can learn to interpret the pulses to regain some visual function, such as detecting light and dark or seeing movement.
“This regulatory approval and the first implants of the Argus II in Canada are tremendous milestones, not only for Second Sight, but also for those affected by outer retinal degenerations in Canada,” said Robert Greenberg, MD, PhD, president and CEO of Second Sight. “Leveraging more than 20 years of research and development, supported by strong intellectual property, and coming on the heels of our approval in the U.S., today’s approval enables us to expand our international network of Centers of Excellence, which offer the Argus II retinal implant, into additional Canadian provinces beyond Ontario.”
Second Sight is currently recruiting additional centers in major metropolitan areas and plans to apply for reimbursement in the provinces where they are established.