Updated Jan. 29, 2014, at 11:10 a.m. with comment from Second Sight Medical.
Second Sight Medical today announced the 1st commercial U.S. implants of its Argus II bionic eye system, which won FDA approval about a year ago.
The Argus II device, which won Medicare reimbursement coverage in August 2013, is designed to help restore some measure of sight to patients with retinitis pigmentosa, a condition that leaves patients with either bare light perception or none at all. There is currently no cure for the rare condition, which is diagnosed about 250 times each year.
Outcomes from the new surgeries won’t be known until patients have had time to go through rehabilitation and training with the Argus II system. The rehabilitation process takes about 3 months and Second Sight plans to provide updates during a press event at the American Society of Cataract and Refractive Surgery conference in April, a company spokesperson told MassDevice.com today.
The 1st-of-its-kind Argus II system is comprised of 2 main components: an eyeglass-mounted camera and an electrical stimulator implanted in the eye. The device converts images captured by the camera into a series of electrical pulses that are transmitted wirelessly to electrodes in the retina to simulate vision.
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The technology, which has had regulatory approvals and reimbursement coverage for years outside the U.S., made major strides in 2013 with FDA approval in February and Medicare reimbursement in August.
"This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now," Second Sight president & CEO Dr. Robert Greenberg said at the time of the FDA decision. "With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant."
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The 1st post-approval implants were conducted at the University of Michigan’s Kellogg Eye Center, which is 1 of 12 "Centers of Excellence" in the U.S. which are accepting Argus II patients. The Kellogg Center already has other patients lined up to receive the Argus II "in coming weeks" and other centers are also poised to conduct their initial implants, according to a press release.
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