Carl Zeiss Meditec Receives FDA Clearance for MEL 80 Excimer Laser Systems
Study Shows 93 Percent Corrected to 20/20 or Better at Three-Month Follow-up
Jena/Germany, Dublin/USA, 23.08.2006. Carl Zeiss Meditec one of the world’s premier medical technology companies, today announced the U.S. Food & Drug Administration (FDA) has cleared the MEL 80™ Excimer Laser System for vision correction eye surgery.
“The FDA clearance of the MEL 80™ for myopic correction is a major milestone achievement in our overall business strategy to provide the most advanced refractive laser technologies worldwide,” said Ulrich Krauss, president and CEO, Carl Zeiss Meditec AG. “With more than 750 excimer systems already delivered to customers around the globe, CZM is well established in the market and the MEL 80™ has proven itself as one of the leading systems. Access to the U.S. market further strengthens our global refractive business.“
Results from clinical studies found that 93 percent of patients were corrected at three months to 20/20 or better visual acuity, and 41 percent were corrected to 20/12.5 or better at six months. Results also showed that 85 percent of patients achieved within one-half of a diopter (optical power measurement) of the intended correction at three months post-operative follow up.
The MEL 80™ Laser is designed to make the correction of vision defects exceptionally effective and patient-friendly. The technology uses a particularly small spot size and Gaussian beam profile, thereby creating a corneal ablation which is even and is protective of the surrounding tissue. The ablation process is also very fast, so there is less dehydration of the eye. The thermally- optimized distribution of the laser firing pattern also protects the stroma, despite the systems high ablation speed. Since the patient only needs to concentrate on the fixation light for a few seconds, patient stress is considerably reduced.
“The MEL 80™ has superior characteristics that make it extremely advanced,” said Mark Packer, M.D., FACS, clinical associate professor, Oregon Health and Science University, Portland, OR, and a principle investigator of the clinical trial. “Because of its speed, the amount of time the cornea is exposed is reduced and the overall treatment procedure is significantly shortened. “Additionally, the laser is able to preserve the natural curvature of the cornea ultimately improving the quality of vision.” continued Dr. Packer.
Preparations for commercial launch of the MEL 80™ in the U.S. are now being finalized. “Our overall strategic intent is to provide not only the most advanced technologies, but also to offer innovative systems solutions that best meet the needs and expectations of our customers. We believe that the excellent results from the FDA clinical studies will further improve the reputation of the MEL 80™ as one of the leading refractive laser systems.” said Jim Taylor, president and CEO of Carl Zeiss Meditec, Inc. “In addition to the advanced excimer laser platform offered by our MEL 80™, we have also pursued the development of an advanced femtosecond laser system for flap creation. The ongoing clinical testing of these femtosecond technologies has been both more rapid and more promising than we had anticipated, and a 510k has recently been filed. As a result, our intent is to bring a truly unique and comprehensive offering to our customers. In the U.S. we prepare an integrated launch of these products.”
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