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FDA PANEL RECOMMENDS APPROVAL OF VISX EXCIMER LASER SYSTEMS


The FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 Ophthalmic Devices Advisory Panel has recommended approval of the VISX Excimer Laser Systems for use in the treatment of from one to six diopters of hyperopia hyperopia (hī'pərō`pēə): see farsightedness. , or farsightedness.

In making its determination, the panel reviewed data from eight U.S. clinical sites.

Commenting on the panel's recommendation, Mark Logan, chairman, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of VISX, stated, "This recommendation is good news and further demonstrates the tremendous technical advantage inherent in our system. The VISX STAR(TM) is capable of correcting myopia, astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye.  and hyperopia without the need for additional devices such as trackers and discs; I believe this is another major benefit for our customers. VISX will be working with the FDA to gain final approval for hyperopia as soon as possible."

Dr. James J. Salz, clinical professor of ophthalmology, University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission , and principal VISX investigator at Cedar Sinai Medical Center in Los Angeles, said, "I have been performing hyperopic laser vision correction with the VISX STAR laser system as part of this FDA clinical trial.

"The clinical results are outstanding and hyperopic laser vision correction has become my favorite refractive refractive

capacity to refract light.


refractive error
a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia.
 surgical procedure, primarily because of the high level of satisfaction reported by these patients. I am extremely hopeful that FDA approval will soon make this exciting procedure available to all VISX users."

VISX is the worldwide leader in the development of refractive laser technology. VISX systems are commercially available in the United States and markets worldwide.

For more information, call 408/733-2020.
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Publication:Biotech Equipment Update
Article Type:Article
Geographic Code:1USA
Date:Sep 1, 1998
Words:247
Previous Article:ENDOSONICS TO ACQUIRE NAVIS
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