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Home > Archive > Lasik Eyes Surgery > December 2004 > Wavefront Hyperopic Correction Approved
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Wavefront Hyperopic Correction Approved
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| Glenn - USAEyes.org 2004-12-16, 9:26 am |
| December 15, 2004 08:30 AM US Eastern Timezone
VISX CustomVue Hyperopia Procedure Approved by the FDA; First U.S.
Custom Wavefront LASIK Approval for Farsightedness and Astigmatism
SANTA CLARA, Calif.--(BUSINESS WIRE)--Dec. 15, 2004--VISX,
Incorporated (NYSE:EYE) today announced that it has received approval
from the U.S. Food and Drug Administration (FDA) to treat hyperopia,
also known as farsightedness, and astigmatism with the VISX CustomVue
laser vision correction procedure.
The CustomVue procedure is the first U.S. approved wavefront-guided
laser treatment for hyperopia. It employs the VISX WaveScan System, a
diagnostic system that captures a comprehensive "fingerprint" of each
eye and generates an individualized treatment for each CustomVue
procedure. As shown in a clinical study, CustomVue has the potential
to deliver better vision than contacts or glasses.
Colman Kraff, M.D., principal investigator at the Kraff Eye Institute,
participated in the VISX multi-center clinical study. Dr. Kraff
stated, "VISX's new CustomVue Hyperopia procedure is a significant
step forward in the treatment of farsightedness. The overall quality
of vision with this new procedure is so superior that I plan to treat
all of my qualified patients with CustomVue Hyperopia."
The VISX clinical study results exceeded all of the FDA required
measurements for safety and effectiveness. A six-month evaluation of
clinical study participants showed that more than four times as many
people were very satisfied with their night vision after the VISX
CustomVue Hyperopia procedure, compared to their night vision before
with glasses or contacts.
Liz Davila, VISX Chairman and CEO stated, "With this approval, VISX
now offers our U.S. doctors the broadest range of wavefront guided
treatments. We believe this further advancement of laser vision
correction technology will enhance our market leadership position,
drive CustomVue conversions, and increase future revenue and profit
opportunities."
About the market for Laser Vision Correction:
Laser vision correction is the most popular form of elective surgery
in the U.S. today, where over 3 million people have undergone the
procedure. According to industry research, there are 50 to 60 million
people in the U.S. that are good candidates for laser vision
correction.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| Brent Hanson - LASIKFRAUD.com 2004-12-16, 9:26 am |
| VISX Claims Credit for Manufacturing a Competitor's Laser
Prospective LASIK patients are not the only recipients of misleading
information from LASIK corporations. Sometimes their own investors are also
the recipients of misleading information, as was the case on Thursday, July
11, 2002, when VISX held a conference call for investors.
During the conference call, Elizabeth Davila, CEO of VISX, made comments to
investors regarding the capabilities of the VISX laser with regard to "All
Laser Lasik". Here is a transcript of the statements:
Investor:
On the radio this morning or this week I heard the first advertisements for
"All Laser Lasik". Do you guys have anything to do with that?
Elizabeth Davila:
That is simply the doctors' way of doing the procedure and it requires a
laser like the VISX laser to do it, and it is obviously the technique that a
particular doctor is using.
Investor:
Ok, thank you.
The statements were made at the following point of time in the conference
call: 1:04:36 -- 1:05:03. An audio recording of conference call was
available for one week at http://biz.yahoo.com/cc/9/18409.html
The statements were misleading because a proprietary laser manufactured by
Intralase is required to perform "All Laser Lasik". There are two major
steps used in performing lasik:
1) Cutting a flap in the cornea.
2) Removing tissue from the cornea with a standard laser.
For many years the flap was cut with an instrument known as the
"microkeratome". However, a newer method of cutting the flap has been
developed by Intralase. This method uses Intralase's proprietary laser to
cut the flap. The theory behind the use of the Intralase laser is that
there is reduced risk to the patient when the flap is cut with a laser.
http://www.intralase.com/documents/salesbrochure.pdf
Therefore, we can see that the "All Laser Lasik" method requires two lasers:
1) The Intralase proprietary laser to cut a flap.
2) A standard laser such as VISX, NIDEK, Bausch & Lomb, LaserSight, etc., to
remove tissue from the cornea.
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| crvc@wyoming.com 2004-12-16, 7:11 pm |
| What about farsightedness and astigmatism caused by LASIK? I didn't
see any mention of fixing complications from prior surgeries.
| |
| Glenn - USAEyes.org 2004-12-16, 7:11 pm |
| The FDA has never approved an excimer laser for the retreatment of an
eye with pre-existing refractive surgery. This is an off-label use of
the device as defined and approved under physician scope of medicine
rules.
One company, Alcon, who manufacturers the wavefront-guided LADARVision
4000 CustomCornea excimer laser has actively been developing a unique
algorithm to perform Complex Wavefront Retreatment (CWR). If FDA
approved or if the data is released, outcomes information may become
available.
The biggest problem with either approval of a device for CWR or data
on CWR is that every eye starts significantly different. It is much
more difficult to evaluate something when the starting point is a
moving target.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Simpledog 2004-12-17, 7:13 pm |
| How long till the rest (B/L, Alcon, etc.) of them come out with it Glenn?
Just a guess will do.
"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:h8r0s0tb0jf498hcrd4ekivpmj6rjo279d@4ax.com...
> December 15, 2004 08:30 AM US Eastern Timezone
>
> VISX CustomVue Hyperopia Procedure Approved by the FDA; First U.S.
> Custom Wavefront LASIK Approval for Farsightedness and Astigmatism
>
> SANTA CLARA, Calif.--(BUSINESS WIRE)--Dec. 15, 2004--VISX,
> Incorporated (NYSE:EYE) today announced that it has received approval
> from the U.S. Food and Drug Administration (FDA) to treat hyperopia,
> also known as farsightedness, and astigmatism with the VISX CustomVue
> laser vision correction procedure.
>
>
> The CustomVue procedure is the first U.S. approved wavefront-guided
> laser treatment for hyperopia. It employs the VISX WaveScan System, a
> diagnostic system that captures a comprehensive "fingerprint" of each
> eye and generates an individualized treatment for each CustomVue
> procedure. As shown in a clinical study, CustomVue has the potential
> to deliver better vision than contacts or glasses.
>
> Colman Kraff, M.D., principal investigator at the Kraff Eye Institute,
> participated in the VISX multi-center clinical study. Dr. Kraff
> stated, "VISX's new CustomVue Hyperopia procedure is a significant
> step forward in the treatment of farsightedness. The overall quality
> of vision with this new procedure is so superior that I plan to treat
> all of my qualified patients with CustomVue Hyperopia."
>
> The VISX clinical study results exceeded all of the FDA required
> measurements for safety and effectiveness. A six-month evaluation of
> clinical study participants showed that more than four times as many
> people were very satisfied with their night vision after the VISX
> CustomVue Hyperopia procedure, compared to their night vision before
> with glasses or contacts.
>
> Liz Davila, VISX Chairman and CEO stated, "With this approval, VISX
> now offers our U.S. doctors the broadest range of wavefront guided
> treatments. We believe this further advancement of laser vision
> correction technology will enhance our market leadership position,
> drive CustomVue conversions, and increase future revenue and profit
> opportunities."
>
> About the market for Laser Vision Correction:
>
> Laser vision correction is the most popular form of elective surgery
> in the U.S. today, where over 3 million people have undergone the
> procedure. According to industry research, there are 50 to 60 million
> people in the U.S. that are good candidates for laser vision
> correction.
>
>
>
> Glenn Hagele
> Executive Director
> Council for Refractive Surgery Quality Assurance
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
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| Glenn - USAEyes.org 2004-12-17, 10:08 pm |
| >How long till the rest (B/L, Alcon, etc.) of them come out with it Glenn?
>Just a guess will do.
Nobody likes anybody to get more than a year ahead.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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