JUL 08, 2013
The Alpha IMS subretinal implant, shown to restore functional vision in patients with severe retinitis pigmentosa, has received CE mark approval.
The implant, from Alpha IMS, is designed to restore vision without externally visible equipment. Thirty-six patients have been implanted with the 3x3 mm2, 1,500-pixel microchip, which is placed beneath the foveal region. Each pixel has a photodiode, an amplification circuit and an electrode to allow an electrical impulse to be delivered to retinal layers corresponding to incoming light. It offers a 10° × 10° diamond-shaped visual field that is roughly 15° diagonal.
Results from the company's second human clinical trial, published earlier this year, showed functional vision improvements, including near vision recognition of faces and door signs. Far-vision improvements included ability to see objects on the horizon.
"We are delighted that our subretinal implant has received CE marking, validating the safety and potential benefits of our revolutionary product to patients and physicians," said Walter-G Wrobel, Ph.D, CEO of Retina Implant AG. "We look forward to working with clinicians across Europe interested in offering their patients a new pathway to regain vision. We also want to thank all of the patients who participated in our clinical trials, as without their contributions, this day would not be possible."