Argus II Retinal Prosthesis System - H110002
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Probable Benefit Data (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Argus II Retinal Prosthesis System
HDE Applicant: Second Sight Medical Products, Inc.
Address: 12744 San Fernando Rd., Bldg #3, Sylmar, CA 91342
Approval Date: February 13, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf11/h110002a.pdf
What is it? The Argus II Retinal Prosthesis System is the first implanted device to treat adults with severe retinitis pigmentosa. The System has three parts: a small electronic device implanted in and around the eye, a tiny video camera attached to a pair of glasses, and a video processing unit that is worn or carried by the patient.
How does it work? The patient wears glasses with an attached video camera that captures images of the surrounding area. These images become an electrical signal which is processed by the video processing unit. The signal is then wirelessly delivered to the eye stimulating the retina. This electrical stimulation of the retina is recognized by the brain as spots of light.
When is it used? The Argus II Retinal Prosthesis System is intended for patients aged 25 years and older with bare or no light perception vision caused by advanced retinitis pigmentosa.
What will it accomplish? The Argus II Retinal Prosthesis System is designed to improve the visual function of patients and may produce the sensation of light. Results of the clinical study showed that the System helped subjects: identify the location or movement of objects and people; recognize large letters, words, or sentences; and helped in other activities of daily life, such as detecting street curbs and walking on a sidewalk without stepping off.
When should it not be used? This device should not be used in patients if they have:
- Ocular diseases or conditions that could prevent the Argus II System from working, including optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, or severe strabismus;
- Ocular structures or conditions that could prevent the successful implantation of the Argus II implant or adequate healing from surgery, including an extremely thin conjunctiva, axial length less than 20.5 mm or greater than 26 mm, or corneal ulcers;
- Ocular diseases or conditions, other than cataracts, that prevent adequate ability to visualize the inner structures of the eye, including corneal opacity;
- An inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implant surgery;
- Any metallic or active implanted device in the head including a cochlear implant.
- Any disease or condition including significant cognitive decline that prevents understanding or communicating informed consent, fitting procedure of the Argus II System, or postoperative follow-up. A confirmatory pre-operative psychological evaluation may be recommended;
- A tendency for rubbing their eyes.
Additional information: The Summary of Safety and Probable Benefit and labeling are available online.