Advanced Medical Optics Receives FDA Clearance For iFS(TM) Advanced Femtosecond Laser
Abbott Laboratories zu myNews hinzufügen Was ist das?
Advanced Medical Optics, Inc. (AMO) (NYSE: EYE), a global leader in
ophthalmic surgical devices and eye care products, today announced U.S.
Food and Drug Administration (FDA) clearance for the iFS™
Advanced Femtosecond Laser.
Capable of creating a corneal flap during the LASIK procedure in less
than 10 seconds, the iFS™
Advanced Femtosecond Laser’s unique inverted
bevel-in side cut angle is designed to provide a virtually effortless
flap lift, increase post-operative flap adhesion and enhance the
biomechanical stability of the post-LASIK cornea. With full
customization capabilities, it also produces an elliptical flap to
enhance surgical options and includes IntraLase-Enabled Keratoplasty
(IEK).
Additional features of the 5th generation
IntraLase femtosecond technology include:
Higher repetition rate
Tighter spot separation; lower energy
High-resolution digital video microscope
New contemporary user interface, keyboard and touch screen
Ergonomic design for maximum surgeon comfort
"The iFS™
laser builds upon an eight-year history of innovation and more than two
million IntraLase femtosecond procedures performed worldwide,”
said AMO Chairman and CEO Jim Mazzo. "This
technology is an integral part of AMO’s
proprietary iLASIK™
technology suite and a tangible example of our commitment to not only
maintain a substantial advantage over competing systems, but also to
provide technologies that advance the standard of vision care medically.” "The new iFS™
laser provides the surgeon with the ability to select LASIK flap
dimensions customizable to individual refractive errors and corneal
anatomy with capabilities such as the elliptical flap option, inverted
bevel-in side cut angle, and increased speed,”
said Perry S. Binder, MD of the Gordon Binder Weiss Vision Institute in
San Diego, California. "This exciting new
laser, combined with the iLASIK technology suite, provides the surgeon
with the most advanced technologies to give their patients the safest
and best outcomes.”
Dr. Binder observed clinical trials of the iFS™
Advanced Femtosecond Laser and served as medical monitor for the
technology prior to its clearance by the FDA. Dr. Kerry Assil was
medical developer of custom oval flaps using the IntraLase FS™
Laser.
The iFS™ Advanced
Femtosecond Laser is available now for order and will be shipped to U.S.
surgeons by the third quarter of 2008.
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive
technologies and support to help eye care professionals deliver optimal
vision and lifestyle experiences to patients of all ages. Products in
the cataract line include monofocal intraocular lenses (IOLs),
phacoemulsification systems, viscoelastics, and related products used in
ocular surgery. AMO owns or has the rights to such product brands as
Tecnis®, Clariflex®
and Sensar® IOLs;
Sovereign®, Sovereign®
Compact and WhiteStar Signature™
phacoemulsification systems with WhiteStar®
technology; Healon®
viscoelastics and the Baerveldt® glaucoma shunt. Products in the refractive line include wavefront
diagnostic devices, femtosecond lasers and associated patient interface
devices; excimer laser vision correction systems and treatment cards,
and refractive implants. AMO brands in the refractive business include
iDesign™, iFS™,
Star S4 IR®,
WaveScan Wavefront®,
Advanced CustomVue™,
IntraLase®,
IntraLasik®
and ReZoom®, Tecnis®
Multifocal and Verisyse® IOLs.
Products in the eye care line include disinfecting solutions, enzymatic
cleaners, lens rewetting drops and artificial tears. Among the eye care
product brands the company possesses are COMPLETE®,
COMPLETE®
Blink-N-Clean®,
Consept®F, Consept®
1 Step, Oxysept® 1
Step, UltraCare®,
Ultrazyme®, Total
Care™ and blink™ branded products. AMO is based in Santa Ana, California, and
employs approximately 4,000 worldwide. The company has operations in 24
countries and markets products in approximately 60 countries. For more
information, visit the company's Website at www.amo-inc.com.
Forward-Looking Statements
This press release contains forward-looking statements about AMO,
including statements by Mr. Mazzo and Dr. Binder and statements relating
to AMO’s competitive advantage, expected
product performance, trends and outcomes, as well as expected shipment
dates. All forward-looking statements in this press release represent
AMO's judgment only as of the date of this press release. Actual results
may differ from current expectations based on a number of factors.
Therefore, the reader is cautioned not to rely on these forward-looking
statements. AMO disclaims any intent or obligation to update these
forward-looking statements. Additional information concerning these and
other risk factors may be found in previous press releases issued by AMO
and AMO's public periodic filings with the Securities and Exchange
Commission, including the discussion under the heading "Risk Factors" in
AMO's 2007 Form 10-K filed in March 2008. Copies of press releases and
additional information about AMO are available at www.amo-inc.com.