Carl Zeiss Meditec Inc. Receives FDA Clearance For MEL 80 Excimer Laser Systems
"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 excimer laser 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 system's 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, Ore., 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 worldwide," 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 U.S. customers by integrating the launch of these products."
About Carl Zeiss Meditec
Built on an unparalleled 150-year heritage of optical innovation, Carl Zeiss Meditec AG (International Securities Identification Number DE000531370) is one of the world's leading eye care solutions providers. Its product line includes systems for the diagnosis and treatment of the four main diseases of the eye: vision defects (refraction), cataracts, Glaucoma and retinal disorders. The company has incorporated its technological expertise into a stream of product innovations throughout the years, from slit lamps and fundus cameras; to the Humphrey® Field Analyzer, recognized as the global standard for Glaucoma detection and management; to its newest applications of lasers as embodied in its leading-edge MEL 80 refractive laser and innovative STRATUSOCT(TM) device for Glaucoma diagnosis.
Since 2005, the company has also been present in the market for intraocular lenses and consumables, and now covers almost the entire value chain of ophthalmic surgery. The company is looking to continue its profitable growth in the future. The planned acquisition of Carl Zeiss Surgical is intended to further supplement the eye surgery product portfolio and to open up additional growth prospects in neuro and ENT surgery. Carl Zeiss Surgical is the leading provider of visualisation solutions in the world in both of these fields.
Carl Zeiss Meditec AG is based in Jena, Germany, with subsidiaries in Pirmasens, Germany (Carl Zeiss Meditec Systems GmbH), the U.S.A. (Carl Zeiss Meditec, Inc.), Japan (Carl Zeiss Meditec Co. Ltd.) and France (IOLTECH S.A.). The rapidly aging global population and other trends are expected to grow the ophthalmic market in the long term. The company is focused on applying innovative optical technologies to protect and enhance vision now and into the future. Thirty-five percent of Carl Zeiss Meditec shares are in free float. The remaining 65 percent are held by Carl Zeiss, one of the world's leading international groups engaged in the optical and opto-electronics industry.
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Contact: Media Contact: Amy Cook For Carl Zeiss Meditec 925.552.7893 Email Contact
Source: Carl Zeiss Meditec, Inc.