FDA clears Argus II ‘bionic eye’ on the market within the US (video)
These within the US affected by blindness as a consequence of retinis pigmentosa (RP) will now be capable of regain some imaginative and prescient bionically for the primary time ever, because of Second Sight’s Argus II retinal prosthesis. The gadget was simply accepted by the FDA on the market stateside after surmounting the identical hurdle in Europe virtually two years in the past — although it was first launched lengthy, lengthy earlier than that. RP is a uncommon genetic illness that inflicts one hundred,000 or so People, destroying photoreceptors within the eye whereas leaving different cells intact. By implanting a tool on the retina that receives a sign from the eyeglass-mounted digital camera, these cells might be stimulated as if receiving mild, inflicting them to transmit a picture to the mind. Because of the restricted variety of electrodes, sufferers would solely be capable of discern mild or darkish, however most have reported higher performance with the system — with the ability to make out the form of a curb whereas strolling, or discerning between mild, gray or darkish coloured socks, as an example. The Argus II has been licensed by the FDA for “humanitarian use,” which means there’s “affordable assurance” that it is protected, and will begin popping up in specialised clinics by the top of the yr.
[Photo credit: Associated Press]
Second Sight Pronounces FDA Approval
Second Sight Medical Merchandise Receives FDA Approval for Argus II System
Argus® II Retinal Prosthesis System is the primary permitted bionic eye within the US with life-altering potential for the remedy of blindness as a result of retinitis pigmentosa
SYLMAR, CA, 14 February 2013 After greater than 20 years of analysis and improvement, Second Sight Medical Merchandise, Inc., the main developer of retinal prostheses for the blind, is happy to announce that it is Argus® II Retinal Prosthesis System (“Argus II”) has acquired U.S. market approval from the Meals and Drug Administration (FDA) to deal with people with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European approval in 2011, and a unanimous suggestion by the FDA’s Ophthalmic Units Advisory Panel in September 2012 that this revolutionary product be made out there to deal with this affected person inhabitants within the U.S.
“We’re thrilled to have the ability to supply the one FDA-permitted lengthy-time period remedy for individuals affected by superior RP,” stated Robert Greenberg, MD, PhD, President and CEO of Second Sight. “With this approval, we look ahead to constructing a robust surgical community in america and recruiting new hospitals that may supply the Argus II retinal implant. This can be a recreation changer in sight-affecting illnesses, that represents an enormous step ahead for the sector and for these sufferers who have been with none obtainable remedy choices till now.”
Argus II is meant to offer electrical stimulation of the retina to induce visible notion in blind people with retinitis pigmentosa and has the capability to supply life-altering visible capabilities to these presently unable to see something besides, at greatest, extraordinarily brilliant lights.
Though the ensuing imaginative and prescient is just not the identical as when these sufferers had regular imaginative and prescient, investigators concerned within the medical trial of the Argus II are keen concerning the approval. “It’s extremely thrilling to have FDA approval to start implanting the Argus II and supply some restoration of imaginative and prescient to sufferers blinded from RP. Within the sufferers which were implanted up to now, the development within the high quality of life has been invaluable,” stated Mark Humayun, MD, PhD, Cornelius Ping’s Professor of Biomedical Engineering, Professor of Ophthalmology, Biomedical Engineering, Cell and Neurobiology, Doheny Eye Institute at College of Southern California. “The truth that many sufferers can use the Argus implant of their actions of every day dwelling comparable to recognizing giant letters, finding the place of objects, and extra, has been past our wildest goals, but the promise to the sufferers is actual and we anticipate it solely to enhance over time.”
With approval from the FDA, the Argus II is slated to be obtainable later this yr in medical facilities throughout the nation. Second Sight will probably be actively including websites to make the remedy extra available and encourages amenities and sufferers to contact them.
“That is an thrilling time for people who find themselves blind from RP. Second Sight’s prosthetic retinal system brings significant hope to tens of hundreds of individuals with superior retinal illnesses,” stated Stephen Rose PhD, chief analysis officer at Basis Preventing Blindness. He provides, “The Argus II has the potential to offer life-altering imaginative and prescient capabilities in addition to elevated mobility and independence.”
FDA approval got here following greater than 20 years of labor within the subject, two medical trials, over $100M in public funding by the Nationwide Eye Institute, the Division of Power, and the Nationwide Science Basis, and a further $100M in personal investments.
About Retinitis Pigmentosa (RP)
RP, an inherited retinal degenerative illness that always leads to almost full blindness, impacts roughly one hundred,000 People. The Argus II System is meant to assist the worst-affected RP sufferers, and this approval was made underneath a Humanitarian Gadget Exemption meant to expedite market introduction of applied sciences meant to deal with smaller, underserved affected person populations.
Concerning the Argus II System
The Argus II System works by changing video pictures captured by a miniature digital camera housed within the affected person’s glasses right into a collection of small electrical pulses which are transmitted wirelessly to an array of electrodes on the floor of the retina. These pulses are meant to stimulate the retina’s remaining cells ensuing within the corresponding notion of patterns of sunshine within the mind. The affected person then learns to interpret these visible patterns thereby regaining some visible perform. Second Sight gained European approval (CE Mark) for the system in 2011 and FDA approval in 2013. It stays the primary and solely authorised retinal prosthesis anyplace on the earth.
About Second Sight
Second Sight Medical Merchandise, Inc., situated in Los Angeles, California, was based in 1998 to create a retinal prosthesis to offer sight to sufferers blinded from outer retinal degenerations similar to RP. By way of dedication and innovation, Second Sight’s mission is to develop, manufacture and market implantable visible prosthetics to allow blind people to realize larger independence. US Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For extra info, go to www.2-sight.com.