[Blindtlk] FDA approves first retinal implant for adults withrare genetic eye disease

Sat Feb 16 23:16:33 UTC 2013

I like how Dr. Maurer put it in a banquet speech: "I have nothing against
waiting, except that it takes so long and is so dull." <Smile.>

Chris

-----Original Message-----
From: blindtlk [mailto:blindtlk-bounces at nfbnet.org] On Behalf Of Mike
Freeman
Sent: Saturday, February 16, 2013 5:33 PM
To: 'Blind Talk Mailing List'
Subject: Re: [Blindtlk] FDA approves first retinal implant for adults
withrare genetic eye disease

I don't disagree.

However, I don't think medical personnel -- especially those doing research
-- present realistic info to those who are champing at the bit to "see"
again.

Mike

-----Original Message-----
From: blindtlk [mailto:blindtlk-bounces at nfbnet.org] On Behalf Of Daniel
Garcia
Sent: Saturday, February 16, 2013 2:17 PM
To: 'Blind Talk Mailing List'
Subject: Re: [Blindtlk] FDA approves first retinal implant for adults
withrare genetic eye disease

My philosophy is that people should have the choice to undergo these
procedures. Although we all agree that being blind is respectable, there is
nothing wrong with medical science providing people the opportunity to
undergo procedures that could improve their sight. Since I don't have RP
this won't help me, but I do think it is a great thing for those that would
want to take advantage of it.

Daniel

-----Original Message-----
From: blindtlk [mailto:blindtlk-bounces at nfbnet.org] On Behalf Of Mark Tardif
Sent: Saturday, February 16, 2013 4:35 PM
To: Blind Talk Mailing List
Subject: Re: [Blindtlk] FDA approves first retinal implant for adults
withrare genetic eye disease

And what contributes to that is that a lot of people have this idea that if
you have the right technology, blindness can be fixed, and wouldn't you want
that as opposed to having to actually adjust?  And we also need to educate
people to the fact that whether or not that is true, blindness has a
plethora of different causes and one single piece of technology isn't
necessarily going to work for everyone.  This is even true with dog guides. 
I can't recall how many times well-meaning people have asked me why I don't
get a dog after they have seen someone do really well with a dog guide, as
if that would solve everything.

Mark Tardif
Nuclear arms will not hold you.
-----Original Message-----
From: Mike Freeman
Sent: Saturday, February 16, 2013 10:02 AM
To: 'Blind Talk Mailing List'
Subject: Re: [Blindtlk] FDA approves first retinal implant for adults
withrare genetic eye disease

Ah ... but that wouldn't tug at the heart-strings ... or is it the
purse-strings?

Just shows how feared blindness is.

Perhaps cutting back on funding for such trifles would be a *good* thing to
come out of sequestration! :-)Mike

-----Original Message-----
From: blindtlk [mailto:blindtlk-bounces at nfbnet.org] On Behalf Of Julie J.
Sent: Saturday, February 16, 2013 6:53 AM
To: Blind Talk Mailing List
Subject: Re: [Blindtlk] FDA approves first retinal implant for adults with
rare genetic eye disease

What I want to know is if the glasses are available in the style like the
visor Jordi had on Star Trek.

Seriously though, it seems like a load of money, time and pain for only
the ability to detect light from dark.   I suppose science has to start
somewhere.  I'm all for modern advancements, but sometimes I think they come
at the expense of the individuals they are supposed to be helping.
My guess is that individuals who undergo this procedure are very scared
about their blindness and could be helped a lot more with some mentoring,
some skill training and some confidence.

Julie

On 2/16/2013 8:37 AM, Mike Freeman wrote:
> It is ironic that a $35 cane would be far more effective than an 
> experimental procedure costing over a hundred grand and that people 
> moan
and
> groan over the cost of Braille displays but would kill to blow their 
> hard-earned funds because of the devices purported ability to make 
> them "see", if that's the word.
>
> Mike Freeman
>
>
> -----Original Message-----
> From: blindtlk [mailto:blindtlk-bounces at nfbnet.org] On Behalf Of 
> Daniel Garcia
> Sent: Saturday, February 16, 2013 6:07 AM
> To: blindtlk at nfbnet.org
> Subject: [Blindtlk] FDA approves first retinal implant for adults with
rare
> genetic eye disease
>
> FDA approves first retinal implant for adults with rare genetic eye
disease
>
> For Immediate Release: Feb. 14, 2013
>
> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339824.ht
> m
>
> The U.S. Food and Drug Administration today approved the Argus II 
> Retinal Prosthesis System, the first implanted device to treat adult 
> patients with advanced retinitis pigmentosa (RP). The device, which 
> includes a small
video
> camera, transmitter mounted on a pair of eyeglasses, video processing 
> unit
> (VPU) and an implanted retinal prosthesis (artificial retina), 
> replaces
the
> function of degenerated cells in the retina (a membrane inside the
> eye)
and
> may improve a patient's ability to perceive images and movement. The 
> VPU transforms images from the video camera into electronic data that 
> is wirelessly transmitted to the retinal prosthesis.
> RP is a rare genetic eye condition that damages the light-sensitive 
> cells that line the retina. In a healthy eye, these cells change light 
> rays into electrical impulses and send them through the optic nerve to 
> the area of
the
> brain that assembles the impulses into an image. In people with RP, 
> the light-sensitive cells slowly degenerate resulting in gradual loss 
> of side vision and night vision, and later of central vision. The 
> condition can
lead
> to blindness.
> "This new surgically implanted assistive device provides an option for 
> patients who have lost their sight to RP - for whom there have been no 
> FDA-approved treatments," said Jeffrey Shuren, M.D., director of the 
> FDA's Center for Devices and Radiological Health. "The device may help 
> adults
with
> RP who have lost the ability to perceive shapes and movement to be 
> more mobile and to perform day-to-day activities."
> The Argus II system is intended for use in adults, age 25 years or 
> older, with severe to profound RP who have bare light perception (can 
> perceive light, but not the direction from which it is coming) or no 
> light
perception
> in both eyes, evidence of intact inner layer retina function, and a
previous
> history of the ability to see forms. Patients must also be willing and
able
> to receive the recommended post-implant clinical follow-up, device
fitting,
> and visual rehabilitation.
> In addition to a small video camera and transmitter mounted on the
glasses,
> the Argus II Retinal Prosthesis System has a portable video processing
unit
> (VPU) and an array of electrodes that are implanted onto the patient's 
> retina. The VPU transforms images from the video camera into 
> electronic
data
> that is wirelessly transmitted to the electrodes. The electrodes 
> transform the data into electrical impulses that stimulate the retina 
> to produce images. While the Argus II Retinal Prosthesis System will 
> not restore
vision
> to patients, it may allow them to detect light and dark in the
environment,
> aiding them in identifying the location or movement of objects or people.
> The FDA approved the Argus II Retinal Prosthesis System 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 for humanitarian use, 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.
> The FDA reviewed data that included a clinical study of 30 study 
> participants with RP who received the Argus II Retinal Prosthesis System.
> Investigators monitored participants for adverse events related to the 
> device or to the implant surgery and regularly assessed their vision 
> for
at
> least two years after receiving the implant.
> Results from the clinical study show that most participants were able 
> to perform basic activities better with the Argus II Retinal 
> Prosthesis
System
> than without it. Some of the activities tested included locating and 
> touching a square on a white field; detecting the direction of a 
> motion; recognizing large letters, words, or sentences; detecting 
> street curbs; walking on a sidewalk without stepping off; and matching 
> black, grey and white socks.
> Following the implant surgery, 19 of the 30 study patients experienced 
> no adverse events related to the device or the surgery. Eleven study 
> subjects experienced a total of 23 serious adverse events, which 
> included erosion
of
> the conjunctiva (the clear covering of the eyeball), dehiscence 
> (splitting open of a wound along the surgical suture), retinal 
> detachment, inflammation, and hypotony (low intraocular pressure).
> Three government organizations provided support for the development of 
> the Argus II. The Department of Energy, National Eye Institute at the 
> National Institutes of Health and the National Science Foundation 
> collaborated to provide grant funding totaling more than $100 million, 
> support for
material
> design and other basic research for the project.
> Second Sight Medical Products, Inc. is based in Sylmar, Calif.
>
>
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