The Argus II Retinal Prosthesis ("Bionic Eye") Receives Medicare Approval
by Maureen Duffy
On August 15, 2013, Second Sight Medical Products, Inc. announced that its Argus® II Retinal Prosthesis System has been approved by the Centers for Medicare and Medicaid Services (CMS) for both a new technology add-on payment (inpatient setting of care) and a transitional pass through payment (outpatient setting of care) beginning October 1, 2013. You can read the complete announcement at the Second Sight website.
The Argus II Implantation Centers
In July, Second Sight Medical Products, Inc., of Sylmar, California, announced that its Argus® II Retinal Prosthesis System, also called the "artificial retina" or "bionic eye," would be offered in 12 implantation centers across the United States to treat patients with severe to profound retinitis pigmentosa (RP).
In preparation for the launch of Argus II later this year, these initial 12 implantation centers will begin to accept consultations with patients who have RP. The centers will be located in Ann Arbor, MI; Atlanta, GA; Baltimore, MD; Chicago, IL; Cleveland, OH; Dallas, TX; Durham, NC; Los Angeles, CA; Miami, FL; Nashville, TN; Philadelphia, PA; and San Francisco, CA.
Some Background: Argus II Development
The Argus II has been approved to treat adults with severe to profound RP, a rare, inherited degenerative disease that damages light-sensitive cells in the retina, resulting in decreased vision at night or in low light; loss of side (peripheral) vision; and loss of central vision as the disease progresses. At present, there is no cure for RP.
The retina is the light-sensitive tissue that lines the inside surface of the eye. Cells in the retinal tissue convert incoming light into electrical impulses. These electrical impulses are carried by the optic nerve to the brain, which finally interprets them as visual images. The Argus II is not a cure for RP; instead, it is intended to replace the function of the light-sensing cells that have been damaged and/or degraded by the disease.
The Argus II device consists of the following components:
- a small video camera
- a transmitter mounted on a pair of eyeglasses
- a video processing unit (VPU)
- an artificial retina (the implanted retinal prosthesis, which is an array of electrodes)
The video camera images are transformed into electronic data by the VPU that sends signals to a wireless receiver implanted in the eye (the retinal prosthesis electrodes). The electrodes allow the electronic signals to bypass the damaged retina and transmit directly to the brain, where they are interpreted as visual images.
The cost of the Argus II is approximately $150,000; additional fees include the implantation surgery and training to use the device. The Second Site website provides an illustrated system overview, including a video animation.
Who Is Eligible for the Argus II?
The Argus II is implanted in a single eye, typically the worse-seeing eye. It is indicated for use in persons with severe to profound RP who meet the following criteria:
- Age 25 or older
- Have bare light or no light perception in both eyes: Bare light perception is the ability to perceive light, but not the direction from which the light is coming. If the person has no residual light perception, then evidence of intact inner layer retina function must be confirmed.
- A previous history of useful form vision
- Be aphakic or pseudophakic: Aphakic means that the eye is lacking its natural lens. Pseudophakic means that the eye has been fitted with an artificial lens implant (as in cataract surgery) to replace the missing or surgically removed natural lens.
- If the person is phakic (i.e., has a natural lens or an artificial lens implant) prior to the Argus II implant surgery, the lens will be removed during the implant procedure.
- Be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.
The Argus II FDA Approval
The FDA approved the Argus II as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4,000 people in the United States each year.
To obtain approval under this designation, a company must demonstrate a "reasonable assurance that the device is safe and that its probable benefit outweighs the risk of illness or injury." The company also must show that there is no comparable device available to treat or diagnose the disease or condition. In the United States, additional clinical trials will need to be completed before the company can seek broader FDA approval.
Argus II Clinical Trial Information
The Argus II clinical trial study group includes 11 locations throughout Europe, the United States, and Mexico. A two-patient pilot study was initiated in Mexico in 2006, followed by a 30-patient trial in Europe and the United States. Two ongoing clinical trials include the Argus® I Clinical Trial and the Argus® II Clinical Trial. Additional clinical trial information is available upon request, via email, at firstname.lastname@example.org.
The following everyday activities were evaluated during the clinical trials:
- detecting the direction of motion
- recognizing large letters, words, or sentences
- detecting and identifying street curbs
- walking on a sidewalk without stepping off
- matching black, gray, and white socks
- locating and touching a square on a white background
- Results indicate that most participants were able to perform these activities better with the device than without it.
While 19 of the 30 study participants did not experience adverse events, 11 study participants experienced 23 harmful outcomes, which included the following:
- retinal detachment
- hypotony (low intraocular pressure)
- erosion of the conjunctiva (the thin, transparent tissue covering the outer surface of the eye)
- dehiscence (the opening of a wound along the surgical suture)
- removal of the Argus II device in two study participants.
Where to Find More Information
Second Sight encourages interested patients and surgical centers to contact the company for more information.
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