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Title: Special Excimer Laser given IDE Approval for Refractive eye Surgery
URL: http://www.pslgroup.com/dg/9B22.htm
Doctor's Guide
June 26, 1996

KING OF PRUSSIA, Pa., June 26, 1996 -- The FDA (U.S. Food and Drug Administration) has given IDE (investigative device exemption) approval for a suburban Philadelphia ophthalmologist's special excimer laser used to perform "under the surface" laser refractive eye surgery. The FDA's approval of the IDE is the first step toward approval for commercial distribution for the laser used by Dr. Frederic Kremer.

While most laser refractive surgery is done on the surface of the cornea, Dr. Kremer's technique involves folding the eye's surface to one side so the underlying tissue can be reshaped and the intact surface cells then replaced. (This has been referred to by some as "LASIK," and is considered to be the next advancement in laser eye surgery). Dr. Kremer has documented results from the over 1,000 LASER-K(SM) procedures (his version of "LASIK") he has performed over the past three years.

Dr. Kremer, who built his own excimer laser in 1991, and performed the first "LASIK" procedure in North America, reports a higher level of patient comfort and more rapid visual recovery.

According to Dr. Kremer, "The LASER-K(SM) procedure has demonstrated highly favorable results, not only for nearsighted patients but for those who suffer from farsightedness and astigmatism. It has been successful on people whose vision starts out at 20/40 and has been improved to 20/20, to people who saw less than 20/200 and were corrected to 20/20, or close to it. In fact, most of the patients have experienced the quality vision they need to do all, or at least most things without glasses, from sports to waking up in the morning to seeing themselves in the mirror, but, like all surgery it is not risk-free. There is a risk of infection, just as there is with the use of contact lenses. While there is also a post-surgical risk of patients seeing halos around lights and/or ghost images, modifications in the LASER-K(SM) procedure now minimize these."

Frederic Kremer, M.D., has published extensively in the field of refractive surgery, including an article in "Annals of Ophthalmology" in 1992 and in "Review of Ophthalmology" in 1994. He has also presented his work at the International Society of Refractive Surgery and the American Society of Contemporary Ophthalmology. He has invented multiple eye surgical instruments, including the ultrasonic pachometer.

/delval/

/CONTACT: Stephanie Simon of Toplin Associates, 215-886-4644, for Dr. Frederic
Kremer/

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