-Fremont, CA, USA, September 30, 1999-
NIDEK, Inc. announced today that the FDA has granted PMA supplement approval for the Company's EC-5000 Excimer Laser System for the treatment of Photorefractive Keratectomy for moderate myopia with astigmatism.
The new approval will allow treatment for the reduction or elimination of moderate myopia (nearsightedness) with astigmatism (uneven curvature of the cornea). The approval will allow correction of myopia ranging in severity from -1.00 to -8.00 diopters (D), with refractive astigmatism from
-0.50 to -4.00 D cylinder by manifest refraction.
Hiroshi Okada, Vice President and General Manager of NIDEK, Inc. states, "this new approval enables physicians to expand current applications of the NIDEK EC-5000. What this means is that doctors can now provide more treatment therapies for nearsighted patients in their practices."
NIDEK's EC-5000 Excimer Laser System is also approved for the reduction and elimination of myopia in the low, moderate and high ranges (-0.75 to -13.00) diopters, using PRK (Photorefractive Keratectomy). "NIDEK is dedicated to providing the best solutions and treatment therapies for quality patient care", states Mr. Okada. "The EC-5000 now provides expanded treatment options and an innovative, technologically advanced package for Refractive Surgery. The platform is designed for the present as well as the future, as the field of Refractive Surgery continues to grow."
Contact: Mr. Mitsutoshi Amano
Title: Manager, Corporate Planning
Phone: +81-533-67-6753
Fax: +81-533-67-6610
Email: mitsutoshi_amano@nidek.co.jp
