The
U.S. Food and Drug Administration (FDA) approved the Argus II retinal
prosthesis system for use in the United States.
Mark
Humayun, who holds joint appointments at the Keck School of Medicine of USC and
the USC Viterbi School of Engineering, was a key member of the team that
developed the device, which will be available to qualified patients at the Keck
Medical Center of USC.
The
Argus II, which received a unanimous recommendation for approval by the FDA's
Ophthalmic Devices Advisory Panel in September, restores some visual
capabilities for patients whose blindness is caused by Retinitis Pigmentosa
(RP), an inherited retinal degenerative disease that affects about 100,000
people nationwide.
"It
is incredibly exciting to have FDA approval to begin implanting the Argus II and
provide some restoration of vision to patients blinded from RP," said Humayun,
Cornelius Pings Professor of Biomedical Sciences and professor of ophthalmology,
biomedical engineering, cell and neurobiology at USC. In the patients that
have been implanted to date, the improvement in the quality of life has been
invaluable.
"The
fact that many patients can use the Argus implant in their activities of daily
living, such as recognizing large letters, locating the position of objects and
more, has been beyond our wildest dreams," Humayun added, "yet the promise
to the patients is real, and we expect it only to improve over time."
The
Argus II, which is manufactured by Sylmar, Calif.-based Second Sight, was
approved for use in Europe in 2011 and has been implanted in 30 patients in a
clinical trial that began in 2007. Humayun performed many of the surgeries to
implant the device.
The
FDA approval paves the way for Second Sight to build a surgical network in the
United States to implant the device, as well as to recruit hospitals to offer
it, according to Robert Greensburg, president and CEO of the company.
The
Argus II system uses a camera mounted on special glasses that sends a signal to
an electronic receiver with 60 electrodes implanted inside the eye.
The
receiver sends signals to the retina that travel through the optic nerve to the
brain, where they can be interpreted as a visual picture. The researchers hope
that one day the device can be improved to also help individuals with
age-related macular degeneration, a similar but far more common disease.
As
the Argus II retinal implant is refined, it will be housed in the USC Institute
of Biomedical Therapeutics. The new $60 million endowed interdisciplinary
institute will bring together scientists, engineers and clinicians from around
the world to study neural networks to develop bioelectronic solutions for the
millions of people impacted by traumatic brain injury, stroke and debilitating
eye diseases.
Funding
for the development of the device came from the National Eye Institute, the U.S.
Department of Energy, the National Science Foundation and private investment.
Additional
Sources:
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Device Offers Partial Vision for the Blind
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