ABBOTT PARK, Ill., July 20, 2015
/PRNewswire/ -- Abbott (NYSE: ABT) announced today the
U.S. Food and Drug Administration approval and launch of the
iDesign Advanced WaveScan Studio System. The system acts as the
"brain" of the LASIK procedure, generating a high-definition scan
that measures and maps irregularities of the eye that may impact
vision. From these measurements, the iDesign System creates an
accurate and personalized LASIK treatment plan based on the unique
"blueprint" of each person's eyes.
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7571951-abbott-idesign-system-3-d-eye-map/
The iDesign System captures more than 1,200 micro readings of
the eye, as well as identifying the shape of the cornea, its
curvature, how light passes through the eye and pupil diameter
under different lighting conditions − all in one, three-second scan
that can be used to precisely correct vision.
Measuring Telescope Mirrors and Now…Eyes
The development of the sensor technology within the iDesign
System was the result of an earlier discovery by Abbott scientists,
which NASA used to accurately measure and shape the mirrors in the
James Webb Space Telescope to ensure it will transmit high
resolution images of deep space back to earth. The telescope is
scheduled to launch in 2018.
Click here to watch a brief video about the iDesign System and
the James Webb Telescope.
"The iDesign System for LASIK is a leap forward for laser vision
correction in the United States,
enabling a highly personalized treatment unique to the vision needs
of each person," said Leonard
Borrmann, head of research and development for Abbott's
vision business. "The same technology used to help build NASA's new
James Webb Space Telescope, which will allow high-definition views
of space, is allowing us to map the human eye with great
precision."
In a clinical study on 334 eyes treated with the iDesign System,
99 percent of patients experienced little or no difficulty with the
clarity of their vision and 97 percent of patients had little or no
difficulty with their daily activities after surgery. In addition,
patients saw significant improvements in their vision while driving
at night and a reduction in glare.
"The iDesign System allows doctors to detect details of the eye
that we were never able to see before," said Edward E. Manche, M.D., director of Cornea and
Refractive Surgery and professor of Ophthalmology at Stanford University School of Medicine. "After
surgery, people who were treated with the iDesign System in a
clinical study reported high satisfaction rates, as well as
improvements in all areas of vision well-being, such as their
quality of vision and vision needed for healthy, active
lifestyles."
With the approval of the iDesign System, more people may now be
eligible for LASIK compared to Abbott's existing WaveScan WaveFront
technology. Doctors can treat higher levels of astigmatism in
people with nearsightedness, a wider range of pupil sizes, and
those who are 18 years of age and older.
The iDesign Advanced WaveScan Studio has been approved in
several countries around the world since 2012, including
China and the European Union.
Abbott, the LASIK market leader and innovator for more than a
decade, pioneered the first wave-front guided LASIK technology that
transformed the vision correction industry. Abbott's iLASIK
treatment is an all-laser, bladeless procedure that shapes the
cornea to help improve a person's vision. Today, more than 15
million iLASIK procedures have been performed on Abbott machines
around the world – with 94 percent of patients seeing 20/20 or
better based on clinical studies. Today's launch of the iDesign
Advanced WaveScan Studio heralds an advance in the use of lasers to
correct vision issues.
The iDesign System is now available for U.S. ophthalmologists
and patients. For more information, visit
www.backinfocus.com. If you are considering LASIK, ask your
doctor about the iDesign System.
Indications and Important Safety Information
Indications: Advanced CustomVue LASIK® (laser
assisted in situ keratomileusis) is a customized wavefront-guided
laser surgery procedure that uses the iDesign Advanced WaveScan
Studio System to measure visual imperfections of your eye and the
STAR S4 IR® Excimer Laser to permanently reshape the
cornea. Advanced CustomVue LASIK treatment is used to correct, or
reduce myopia (nearsightedness) with and without astigmatism for
patients 18 years of age and older and whose vision has been stable
for at least one year. Only eye care professionals trained in laser
vision correction can determine whether you are a suitable
candidate.
Contraindications:
You should not have LASIK if you have collagen vascular (e.g.,
rheumatoid arthritis), autoimmune (e.g., lupus), or
immunodeficiency diseases (e.g., AIDS) because they affect the
body's ability to heal. You should not have this procedure if you
are pregnant or nursing; show signs of corneal abnormalities or
corneal thinning; have symptoms of significant dry eyes; advanced
glaucoma; and uncontrolled diabetes. If you have severely dry eyes,
LASIK may increase the dryness, may delay healing after surgery,
may or may not go away and it may result in poor vision after
LASIK.
Warnings and Precautions: LASIK is not recommended if you
have cataracts, corneal scars, or dry eye syndrome; glaucoma;
diabetes; severe allergies; history of Herpes simplex or Herpes
zoster keratitis; are taking Isotretinoin (Accutane®
brand), Sumatriptan (Imitrex® brand), Amiodarone
hydrochloride (Cordarone® brand) or antimetabolites for
any medical conditions; history of crossed eyes; previous corneal,
intraocular surgery, LASIK or refractive surgery; family history of
degenerative corneal disease; and history of inflammation of the
eye. Your doctor will examine your eyes to determine if you are a
candidate for this procedure. Talk to your doctor about any
eye-related conditions, injuries, or surgeries you have had, any
medications you are taking, and any changes to your vision in the
past year. After surgery, you may find it more difficult to see in
conditions such as dim light, rain, snow, fog, or glare from bright
lights at night. Future measurements of your eye pressure or future
cataract surgery can be affected by this procedure. Tell your
future doctor you've had Advanced CustomVue LASIK surgery.
Risks:
As with any surgical procedure there are risks associated with
Advanced CustomVue LASIK treatments. It is important to discuss
these risks with your doctor before you make any decision to have
the surgery. If the results of the surgery are not satisfactory,
your doctor may want to perform additional laser treatment in
either one or both eyes. Talk to your doctor about what is best for
you. Some risks are related to the creation of the corneal flap.
Corneal flap complications include but are not limited to: cutting
an incomplete, irregular flap or free flap; misalignment of the
flap; and perforation of the cornea. Corneal flap complications
range in severity from those that simply require the treatment to
be postponed for several months, to those which create corneal
irregularities resulting in permanently blurred vision. You may
need reading glasses even if you did not wear them before. Your
vision may not be perfect, and you may need to wear glasses or
contact lenses for some activities even after laser vision
correction.
Side Effects:
Possible side effects include loss of vision and visual
disturbances such as double vision, sensitivity to bright lights,
increased difficulty with night vision, fluctuations in vision, and
other visual irregularities that may be debilitating.
Please consult with your eye care professional and carefully
review the Patient Information Booklet regarding the potential
risks and benefits of this procedure. Results may vary for each
individual patient.
Caution:
U.S. Federal Law restricts this device to
sale, distribution, and use by or on the order of a physician or
other licensed eye care practitioner.
About Abbott:
At Abbott, we're committed to helping
you live your best possible life through the power of health. For
more than 125 years, we've brought new products and technologies to
the world -- in nutrition, diagnostics, medical devices and branded
generic pharmaceuticals -- that create more possibilities for more
people at all stages of life. Today, 73,000 of us are working to
help people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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SOURCE Abbott