NIDEK Announces International Sale of Excimer Laser for Customized Ablation
Surgeons can now provide customized LASIK procedures using NAVEX
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IMPORTANT:
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(Caution for the United States)
Customized ablation is not approved by the FDA, and the NAVEX has not been cleared by the FDA for distribution in the Unites States.
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-Gamagori, JAPAN, October 3, 2001-
NIDEK Co., Ltd. announced today that the NIDEK Advanced Vision Excimer Laser System (NAVEX) would be available for international sale. NAVEX includes four components - the NIDEK OPD-ScanTM, Final FitTM Software, the Eye Tracker System and the MultipointTM Segmental Ablation hardware upgrade - to perform customized ablation with the NIDEK EC-5000 Excimer Laser System.
"NAVEX will change the way that laser vision correction procedures are performed," commented Hideo Ozawa, President and owner of NIDEK Co., Ltd. "This sophisticated medical technology provides all the tools for a customized ablation procedure, helping surgeons identify the optimum visual outcome and making it a reality for their patients. Surgeons can now treat patients who previously chose to wear glasses or contacts. This system provides those patients with more freedom through its expanded treatment options."
Howard V. Gimbel, MD, MPH, FRCSC, Founder, Medical Director, and Senior Surgeon of the Gimbel Eye Centre, commented, "From the OPD-Scan measurements to the refractive surgery treatment, NAVEX allows surgeons to utilize the technology and precision of the system to make customized ablations for individual patients. In cases where complicated diagnoses and unique treatments are needed, surgeons can be confident with NIDEK's advanced instrumentation."
OPD-ScanTM
The NIDEK OPD-ScanTM is a state-of-the-art diagnostic instrument that combines Wavefront analysis technology with corneal topography to map the aberrations of the entire optical system, presented in the form of unique refractive power maps for the individual eyes of each patient. Incorporating corneal topography, aberrometry autorefraction and autokeratometry all in one device, the OPD-Scan allows simultaneous data acquisition in 0.4 seconds with the same axis of alignment for all measurements.
Final FitTM Software
NIDEK's unique Final Fit Software was created to evaluate data from the OPD-Scan to determine the customized ablation parameters. The software converts data from the individual refractive maps into sphere, cylinder and irregular components that create the total ablation profile needed to produce the precise customized ablation parameters for the patient's eye. Final Fit software is intended to ensure that the surgery corrects the corneal shape and unique, subtle optical aberrations, providing the finest optical results. The resulting data is then transferred to the EC-5000 for the refractive surgery procedure.
Eye Tracker System
The NIDEK Eye Tracker System utilizes high-speed digital video camera technology to follow the patient's eye ensuring laser alignment during the procedure. This is an active tracking, closed loop system, which locks onto the eye and tracks the eye's movement independent of hydration or shape changes during surgery.
MultipointTM Segmental Ablation System
In conjunction with NIDEK's clinically proven scanning-slit technology, the Multipoint Segmental Ablation System divides the rectangular-shaped laser beam into six small equal segments, which can be individually or simultaneously projected onto the cornea for a more efficient treatment.
The Multipoint Segmental Ablation System enables the EC-5000 to direct the excimer laser beam to smaller, more specific areas on the corneal surface requiring additional treatment to compensate for subtle irregularities and aberrations of the eye.
"This system is a major advancement in integrated medical technologies for refractive surgery and ophthalmology," said Arturo Chayet, MD, Medical Director of the Codet-Aris Laser Institute and 2000 recipient of the International Society of Refractive Surgery's prestigious LANS Award. "Each component of NAVEX is backed by 30 years of sophisticated medical technology and engineering experience."
