People who suffer from retinitis pigmentosa (RP) have retinas that deteriorate over time, leading to progressive loss of sight. But last week, a U.S. Food and Drug Administration (FDA) panel unanimously voted to allow the Argus II Retinal Prosthesis System – a device that may partially restore vision – to go forward for approval, saying the potential approval of the device “outweighs the risks to health,” according to a story at Medical Design Technology.
In making its decision, the panel spent 10 hours carefully reviewing and discussing data submitted from the international clinical trial of this retinal implant, manufactured by Second Sight Medical Products.
The panel, which included 19 voting members with expertise in ophthalmology, retinal disease, low vision, electrophysiology and other specialties, heard testimony from the sponsor, FDA, and several doctors and participants involved in the most recent clinical trial that began in 2007.
“We are looking forward to working with the FDA now to quickly get the product approved,” said Anne-Marie Ripley, vice president of clinical and regulatory affairs at Second Sight. “There is no therapy available currently for these patients and we would like to make Argus II available to American doctors and their patients as soon as possible.”
“Modest gains in vision can make a big difference to a person blinded by retinitis pigmentosa,” said Paul Sieving, MD, director of the National Eye Institute. “The Argus II retinal prosthesis allows users to reclaim their independence and improve their lives.”
In another FDA move, the agency told Medical Design Technology that it has approved “a first-of-a-kind heart-zapping implant from Boston Scientific that that does not directly touch the heart.”
Implantable defibrillators use thin wires to send electrical signals that disrupt dangerous heart rhythms. Surgeons have traditionally connected the wires to the heart through a blood vessel in the upper chest.
The new device from Boston Scientific uses wires that sit just below the skin's surface and do not need to be threaded through the heart's blood vessels.
In 2008, over 616,000 people died of heart disease, according to the CDC. Heart disease caused almost 25 percent of deaths – one in every four – in the United States.
Edited by
Braden Becker
