-Gamagori, JAPAN December 4th, 2003-

NIDEK Co. Ltd. announced that it has received CE Mark approval for its Customized Aspheric Treatment Zone (CATz) software for the NIDEK EC-5000 Excimer Laser System.This regulatory milestone clears the way for NIDEK to market its laser and custom treatment algorithm, known as CATz, throughout European Union for the correction of myopia with or without astigmatism.

"With this approval, NIDEK takes 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," said Hideo Ozawa, president of NIDEK Co., Ltd. "NIDEK can now provide an innovative system designed to improve refractive outcomes for patients in Europe with wide ranges of myopia and astigmatism," added Mr. Ozawa.

CATz uses a proprietary ablation algorithm based on topography data that employs smooth treatment zones to create a seamless transition from the treated cornea to nascent (untreated) cornea. Aberrations based on corneal irregularities can result in visual blur and other undesired visual phenomena are reduced with this ablation algorithm. This results in a shorter visual recovery period and better post-operative visual acuity.

The clinical data submitted to gain CE mark approval showed excellent clinical outcomes with 93 percent of patients having an uncorrected visual acuity of 20/20 or better. In addition, 20 percent of patients gained at least one line of best-corrected visual acuity. Ninety-seven percent of patients were within 0.50 diopters of the targeted refractive correction. Root mean square values of all the higher order aberrations including, coma and spherical aberrations were lower than pre-operative levels. Average contrast sensitivity was maintained three months post-operatively, indicating the potential of excellent quality of vision after the procedure. Additionally, none of the patients lost two or more lines of BSCVA post-operatively.

"The use of CATz in excimer laser vision correction potentially increases the quality of vision while addressing two major issues in refractive surgery: induced spherical and other higher order aberrations that can occur post-ablation. We expect an unsurpassed level of patient and physician satisfaction with this improvement in refractive surgery," noted Mr. Ozawa.

The CE Mark is an indication that a company has met essential health, safety and environmental protection requirements detailed in 22 European Directives covering an array of products including medical devices. The CE Mark allows products to gain access to the EU market, assuring physicians and patients of the safety of the product.


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