-Gamagori, JAPAN November 11, 2003-

NIDEK Co. Ltd announced today the submission of the NIDEK EC-5000 Excimer Laser System's Customized Aspheric Treatment Zone (CATz) for CE Marking in the treatment of myopia with and without astigmatism. The CATz ablation algorithm employs smooth treatment zones to create a seamless transition from the treated cornea to nascent (untreated) cornea in order to achieve a faster visual recovery period and better visual acuity. The use of this approach potentially increases optical performance and reduces the emergence of imperfections, or aberrations, that result in visual blur and other undesired visual phenomena.

The CE Mark is an indication that a company has met essential health, safety, and environmental requirements detailed in 22 European Directives covering an array of products including medical devices. Once a company has met the requirements, it can affix the CE Mark to its products and sell them throughout the European market. Compliance to EU Directive requirements is certified by a notified body, which is nominated by an EU member government and notified by the European Commission. The notified body for NIDEK is TÜV Product Service GMBH, Germany. "By submitting the CATz algorithm data for permission to affix the CE Mark to a Class IIb device, NIDEK has taken an exciting step forward in providing our European customers and patients with the best possible clinical outcomes in the market today for laser vision correction. This is an exciting development that will enable large numbers of patients to benefit from better vision and excellent clinical outcomes," said Hideo Ozawa, President of NIDEK Co., Ltd. With the submission of documentation that would permit the use of the CE Mark, NIDEK can clear the way to market the product in Europe, providing ophthalmologists with an innovative system designed to improve effective outcomes for their patients seeking visual correction for high degrees of myopia and astigmatism.

Furthermore, Mr. Ozawa stated, "The study data for CATz has demonstrated the efficacy of the algorithm. By using CATz, ophthalmologists can now offer further customization and provide better patient outcomes in enhancing visual quality for their patients and decreasing higher order aberrations." The CATz ablation algorithm employs smooth treatment zones to create a seamless transition from treated cornea to nascent cornea. The use of this approach potentially increases the effective optical acuity and decreases the induced spherical aberration post ablation, thus addressing two major issues in refractive surgery: induced spherical and other higher order aberrations. The CATz study reported excellent clinical outcomes with 93 percent of patients having an uncorrected visual acuity of 20/20 or better. Furthermore, 20 percent of patients gained at least one line of best-corrected visual acuity. 97 percent of patients reported results within 0.50 D of the targeted refraction. Root mean square value of all the higher order aberrations, coma, and spherical aberrations were all lower than pre-operative levels. The average contrast sensitivity was maintained three months post-operatively, indicating the potential of excellent quality of vision after the procedure.

Contact:
Ms. Hiromi Kitagawa
Public Relations, Planning Dept.
Phone: +81-533-67-6753
Fax: +81-533-67-6610
Email: info@nidek.co.jp