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

Sun Feb 17 00:08:25 UTC 2013

    I guess the main frame of the justiffication of healthcare
expendetures should be elective surgery or essential surgery right?
I'd rather this type of technology continue to be subsedized by
federal funding and privately sold to individuals for further
development. This is not ready for prime time for the vast majority of
rp patients out there not at all. However, it obviously does help some
in navigation and some print that can be a great thing just not to
justify the price for tax payers yet.

    On other news, my eye disease LHON (lebers hereedetary optical
neuropathy) is getting ccloser to being cured! The National Institutes
of Health under their NEI division funded a five year pilot program
with gene therapy threw the University of Miami. Now apparently the
chief investigator Dr John Guy has fixed one strain of the three
mutations in gene therapy at the University of Miami! This happened in
May 2012 and now heis working on fixing al three in chimpanzes and
then with further approval in humans with the Food and Drug
Administration.

    Lastly, there is hope that many forms of blindness will be cured
in our lifetimes! I'm extremely optimistic tha this will happen to me
within a decade with ongoing international collaberations like the
University of Miami and others on this critical research! I don't want
you guys to give up hope cause hope always exists! We just might have
jumped the gun in thinking that this will be ready or operational till
the fix rp now. Hope this gives another side of the anticipation
towards fixing rp and relatted blindness issues.


hugs,
Peter

On 2/16/13, Mark Tardif <markspark at roadrunner.com> wrote:
> 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.htm
>>
>> 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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-- 
Cordially,
Peter Q Wolfe, BA
cum laude Auburn University
e-mail: yogabare13 at gmail.com
"If you don't stand up for something your willing to fall for anything"
Peter Q Wolfe
"Stand up for your rights"
Bob Marley