FREMONT, Calif., June 17, 2004 (PRIMEZONE) -- NIDEK Inc. announced today that it has received FDA approval for commercial distribution in the United States of its advanced 200 Hz Eye Tracker for use with the NIDEK EC-5000 Excimer Laser System. The NIDEK EC-5000 Excimer Laser System is approved for commercial distribution in the U.S. for LASIK and PRK for myopia with or without astigmatism. The advanced infrared eye tracker is also a key element of NIDEK's future developments of the NAVEX (NIDEK Advanced Vision Excimer Laser) customized ablation platform for refractive surgery.
The 200 Hz Eye Tracker, which has been in use internationally for several years, enhances the functionality and utility of the current laser platform, and will continue to offer the refractive surgeon in the United States an exceptional tracking mechanism for use with the currently approved NIDEK EC-5000 Excimer Laser System. "The powerful and extremely accurate 200 Hz Eye Tracker offers additional capabilities for the NIDEK EC-5000 Excimer Laser Platform in the US market and delivers on our commitment to work towards getting the overall NAVEX Platform approved for use in the United States," stated Ted Shimomura, Executive Vice President and General Manager, NIDEK, Inc. "The new 200 Hz CCD camera eye tracker system constantly monitors the position of the patient's undilated pupil and is not affected by instruments passing in and out of the surgical field. The tracker works by iris detection and multiple infrared beams. Some of the key features of the new eye tracking system include both active and passive tracking of the eye. The eye tracking system does not require dilation of the pupil, pre-tracking and pre-imaging of the patient's eyes, unlike other eye trackers available in the marketplace. A unique feature of the NIDEK 200 Hz Eye Tracker is that it enables the surgeon to choose where to centrate the tracker. The new tracker also works well with an open or lifted LASIK flap. With the approved system, surgeons can image the tracked eye and separately the treated eye. Future applications for this eye tracker include cyclotorsion detection and tracking. The eye tracker's accuracy is ideally suited to NIDEK's unique scanning slit technology and will be integrated into the future investigational studies of the NIDEK NAVEX Platform."
With worldwide operations headquartered in Gamagori, Japan, NIDEK develops, manufactures, and sells laser systems and diagnostic equipment for 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, retinopathy of prematurity, and pre and post-operative cataract surgery therapy. Its 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.
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