Nidek Receives Amended Medical Device License
from Health Canada
Surgeons can now treated farsighted patients
GAMAGORI, Japan, June 4, 2001 - Nidek Co., Ltd., a worldwide manufacturer of ophthalmic and optical equipment, announced today that Health Canada has issued an amended Medical Device License for the Nidek EC-5000 Excimer Laser System. Nidek has received the amended license for the EC-5000 for the treatment of hyperopia with and without astigmatism using the LASIK procedure.
The Nidek EC-5000 is now approved by Health Canada to treat myopia (nearsightedness) and hyperopia (farsightedness) using the following procedures:
LASIK for hyperopia:
0 to +6.0 diopters (D) in terms of manifest refraction spherical equivalent (MRSE) with or without a refractive astigmatism up to +4D cylinder
LASIK for myopia:
-1.0 to -14.0D MRSE with or without astigmatism of 0 to -4D cylinder
PRK for myopia:
-0.75 to -13.0D in terms of spherical equivalent with 0.75D astigmatism
PARK for myopia:
-1.0 to -8.0D in terms of MRSE with astigmatism of -0.5 to -4.0D cylinder
"The EC-5000 platform is designed to expand and support different treatment parameters and options," commented Hideo Ozawa, President of Nidek Co., Ltd. "Without needing to purchase an entirely new system, the EC-5000 platform allows refractive surgeons to offer the treatments their patients require for better vision. "
In the United States, the EC-5000 Excimer Laser System has been approved by the Food and Drug Administration for the reduction and elimination of myopia with and without astigmatism in LASIK and PRK procedures. The Nidek EC-5000 Excimer Laser System is currently being evaluated for its ability to safely and effectively treat hyperopia with and without astigmatism as part of the LASIK procedure.
With U.S. operations headquartered in Fremont, California, Nidek, Inc. sells and distributes laser systems and diagnostic equipment developed and manufactured by Nidek Co., Ltd., for uses in ophthalmology, optometry, general surgery, gynecology and cosmetic dermatological surgery. The Company's ophthalmic and optometric products are specifically designed for diagnosing and treating retinal diseases, glaucoma, refractive therapies, premature retinopathy, and pre- and post-operative cataract surgery therapy. Nidek's surgical products are designed to treat patients in the growing applications of cosmetic laser surgery and laser skin resurfacing. Nidek distributes its products through a network of distribution partners and a direct sales force.
June 5, 2001