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FDA Approval of Argus II
Thank you for your interest in the Argus II Retinal Prosthesis made by Second Sight Medical Products.
Our device received FDA approval for commercial sale in the United States February 14, 2013. We have been commercially available in Europe for over one year and have approximately 22 commercial patients in Italy, Germany and Saudi Arabia. During our clinical trials we implanted an addition 32 subjects who still have our device as well.
The device has been approved for candidates who have the following conditions:
• Adults age 25 or older with Retinitis Pigmentosa (this is the only diagnosis currently approved for our device). We will be working with the FDA on the approval of additional diagnosis pertaining to retinal degeneration in the future.
• Bare light or No light perception in both eyes (If the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed).
• Previous history of use form vision.
• Aphakic or pseudophakic (if the patient is phakic prior to the implant, the natural lens will be removed during the implant procedure).
• Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting and visual rehabilitation.
The device will be available in limited locations in 2013.
• The following cities will have centers opening in July 2013 (should be ready to accept patients for screening sometime in July-August 2013). San Francisco-CA, Los Angeles-CA, Dallas-TX, Atlanta-GA, Miami-FL, Nashville-TN, Raleigh-NC, Baltimore-MD, Philadelphia-PA, Cleveland-OH, Ann Arbor, MI and Chicago-IL.
• An implant is attached via a silicone band to the eyeball, a small incision is made to the eye and an electrode array is tacked to the retina. The incision is closed and there is no indication outside the body of an implant.
• The surgery is done either via a one night hospital stay or as an outpatient procedure depending on the surgeon’s considerations, this will be discussed during the initial testing with the hospital. General Anesthesia (you will not be awake) is used for the surgery.
• As with any surgical procedure or implantable device there are risks, please discuss with your implanting physician directly.
How it works
• Our website illustrates how the device delivers sight via our implant. Please visit our site, here.
• We are currently working with CMS to obtain a procedure code for our device that will allow reimbursement for Medicare. We have preliminary codes for both in and outpatient procedures and are awaiting further instructions and clarification from Medicare.
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