CLEVELAND -- University Hospitals (UH) Eye Institute will be one of the first medical centers in the United States to offer the Argus® II Retinal Prosthesis System ("Argus II").
The Argus II is the first and only "bionic eye" to be approved in countries throughout the world, including the U.S. It is used to treat patients with late stage retinitis pigmentosa (RP). Argus II was developed by Second Sight Medical Products, Inc., located near Los Angeles.
In preparation for the launch of Argus II later this year, implanting centers, including UH, will soon begin to accept consultations for patients with RP. UH is one of a select number of medical centers in 12 major markets in the nation, and the only one in Cleveland and the state of Ohio, chosen by Second Sight to offer the Argus II, which received FDA approval earlier this year.
Argus II works by converting video images captured by a miniature camera, housed in the patient's glasses, into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some visual function.
"This is a remarkable breakthrough," said Suber S. Huang, MD, MBA, Director, UH Eye Institute's Center for Retina and Macular Disease, who also served as the Independent Medical Safety Monitor for clinical trials of the system and gave the summary closing to the FDA Ophthalmic devices panel.
"The system offers a profound benefit for people who are blind from RP and who currently have no therapy available to them. Argus II allows patients to reclaim their independence and improve their lives."
RP is a rare inherited, degenerative eye disease that often results in profound vision loss to the level of bare light perception or no light perception. It affects nearly 100,000 Americans. Noted Cleveland businessman and professional sports owner Gordon Gund is blind from this disease.
"We are thrilled that several of the nation's top hospitals will be the first to offer Argus II to patients in the U.S.," said Brian Mech, Vice President of Business Development, Second Sight. "After an intensive and difficult selection process, these sites were chosen for their cutting-edge approach to medicine and unparalleled commitment to patient care. We are confident that RP patients seeking treatment at these centers will benefit greatly from the best-in-class services these sites provide."
Argus II had more than 20 years of work in the field, three clinical trials, more than $100 million in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100 million in private investment.
"Second Sight conducted a highly competitive selection process and noted the UH Eye Institute's Center for Retina and Macular Disease as 'exemplary' and our collaboration with the Cleveland Sight Center, under the leadership of Dr. Steven Friedman, as a model program," said Dr. Huang, who also is the Philip F. and Elizabeth G. Searle-Suber Huang, M.D., Professor of Ophthalmology and Vice-Chair, Department of Ophthalmology & Visual Sciences at UH and Case Western Reserve University School of Medicine.
Dr. Huang notes that the Argus II program is the latest in a list of remarkable recent achievements in vision research for the Department of Ophthalmology and Visual Sciences, including expansion of its Retina Diseases Image and Cornea Image analysis reading centers which work with eye clinicians and researchers from around the world, award of the $12.4 million Cornea Preservation Time Study, ongoing excellence of numerous clinical research programs, and recognition of being the 5th best National Institutes of Health-funded vision research program in the country (funding to Case Western Reserve University School of Medicine).
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About Retinitis Pigmentosa
RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans and has been designated by the World Health Organization as an orphan disease. In 2009, the Argus II, which is intended to help the worst affected RP patients, received a Humanitarian Use Designation (HUD), making it a candidate for an HDE approval which is intended to expedite the market introduction of technologies intended to treat smaller, underserved patient populations.
About University Hospitals
University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. University Hospitals Case Medical Center is the 2012 recipient of the American Hospital Association - McKesson Quest for Quality Prize for its leadership and innovation in quality improvement and safety.
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About the Argus II System
The Argus II System works by converting video images captured by a miniature camera housed in the patient's glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina's remaining cells, resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function.
About Second Sight
Second Sight Medical Products, Inc., located near Los Angeles, California, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations such as RP. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. US Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit http://www.