Healthcare Industry News: Glaucoma
News Release - May 14, 2008
Advanced Medical Optics Receives FDA Clearance For iFS(TM) Advanced Femtosecond LaserNew 5th Generation Laser Essential Part of iLASIK(TM) Technology Suite
SANTA ANA, Calif.--(HSMN NewsFeed)--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 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.
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.
Source: Advanced Medical Optics
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