Press Release
Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens
- Premium Lens Provides Medicare Beneficiaries With New Option
March 10, 2010
Des Plaines, Illinois — Abbott (NYSE: ABT)
announced today it has received U.S. Food and Drug Administration (FDA)
approval for the TECNIS® Multifocal 1-Piece intraocular lens (IOL) for cataract
patients with and without presbyopia.
Intraocular lenses are implanted in a patient's eye after the removal of the
natural lens that has become clouded by a cataract. Conventional monofocal IOLs
are designed to focus primarily at one distance and do not correct presbyopia,
an age-related change in vision that occurs when the eye's natural lens can no
longer adjust its focal length to allow clear vision at different
distances.
The TECNIS lens has also received presbyopia-correcting IOL status by the
Centers for Medicare and Medicaid Services (CMS), providing Medicare
beneficiaries with the option to receive a TECNIS Multifocal 1-Piece lens for
an additional fee as part of cataract surgery.
"With this approval, Medicare cataract patients have a new opportunity
to enjoy near, intermediate and distance vision without needing glasses, with
nearly 9 out of 10 patients reporting that they never wear glasses following
surgery," said Jim Mazzo, senior vice president, Abbott Medical Optics.
"As an added benefit, surgeons now have the clinical benefits and high
patient satisfaction rates they have come to expect with the TECNIS Multifocal
3-Piece IOL in a next-generation, easy to insert, one-piece design."
The TECNIS Multifocal 1-Piece IOL is a pupil-independent, full diffractive
presbyopia-correcting lens designed for optimal image quality at all distances
under any lighting condition. Its unique optic design gives patients superior
near vision and reading speed compared to other presbyopia-correcting IOLs.
Other features/benefits include:
- Patented wavefront-designed aspheric anterior surface designed to reduce
average spherical aberration to essentially zero
- Reduction of chromatic aberration for better image quality
- Next-generation, easy-to-insert one-piece design
"I look forward to incorporating the TECNIS Multifocal 1-Piece IOL into
my practice for patients who desire spectacle independence," said Kerry
Assil, M.D. "I've been extremely pleased with the pupil-independent
performance of the prior design and anticipate the same inherent benefits will
be demonstrated by the TECNIS Multifocal optic lens on the one-piece
platform."
TECNIS multifocal IOLs are indicated for primary implantation for the visual
correction of adult patients with and without presbyopia in whom a cataractous
lens has been removed and who desire near, intermediate, and distance vision
with increased spectacle independence. The intraocular lenses are intended to
be placed in the capsular bag. Abbott has begun shipping TECNIS Multifocal
1-Piece IOLs in select markets and plans for full commercial shipments to begin
in April 2010.
Additional information about TECNIS multifocal IOLs, including important
safety information, is available at www.abbottmedicaloptics.com.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs
approximately 83,000 people and markets its products in more than 130
countries.
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