FDA okays Advanced Medical Optics' iFS Advanced Femtosecond Laser for eye surgery
May 14, 2008 -- Advanced Medical Optics Inc. (AMO) (NYSE: EYE), a global producer of ophthalmic surgical devices and eye care products, says the U.S. Food and Drug Administration (FDA) has issued clearance for the company's iFS Advanced Femtosecond Laser.
Capable of creating a corneal flap during the LASIK procedure in less than 10 seconds, the iFS Advanced Femtosecond Laser features an inverted bevel-in side cut angle that 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).
The iFS is AMO's 5th generation laser, and part of the company's iLASIK technology suite. Other features of the 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.
"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.
Thu May 15 08:16:00 CDT 2008
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