NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved its highly innovative Customized Aspheric Treatment Zone (CATz) for the NAVEX Quest; EC-5000 Excimer Laser System, one of the first topography-assisted LASIK procedure.
NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved its highly innovative Customized Aspheric Treatment Zone (CATz) for the NAVEX Quest; EC-5000 Excimer Laser System, one of the first topography- assisted LASIK procedure. Measurement points of the topography-assisted LASIK are not restricted by the pupil diameter. The CATz treatment provides a customized unique correction for patients utilizing the NIDEK OPD-Scan measurement system together with the Final Fit software. Final Fit is NIDEKâ€™s proprietary software that allows custom topography-assisted surgery.
Surgeons are finally able to treat myopic astigmatism with corneal irregularities with the CATz treatment. According to George O. Waring, III, MD, principal investigator of the US FDA Study, â€œthe outcomes of the CATz study are astoundingly good â€“ even with no individual center nomogram adjustment. One hundred thirty- three eyes evaluated from four centers at six months, showed improved visual acuity. More than 91% of patients were within Â±0.5D of intended correction. Most excimer laser algorithms treating myopia and astigmatism increase higher order aberrations. In the conventional treatment, the RMS total higher order aberrations increases approximately 0.25 microns, but with topography-assisted LASIK, the increase was 0.08 microns.â€
Mr. Motoki Ozawa, President of NIDEK stated, â€œWe are pleased to have this approval, and confident the results reflect the quality of our laser. These results from 133 eyes demonstrate NIDEKâ€™s commitment to providing an innovative, technologically superior excimer platform for laser vision correction surgery.
Furthermore, NIDEK is actively developing its own custom ablation and wavefront technology platform. The NAVEX Quest; EC-5000 Excimer Laser System is a perfect pairing to NIDEKâ€™s strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products for vision care.â€
The following chart demonstrates the six-month follow up results of the safety and effectiveness of the Topography-Assisted LASIK clinical study:
Six Month Follow Up Results (133 Eyes): 49% 20/16 or better (UCVA)
89% 20/20 or better (UCVA) 95% 20/25 or better (UCVA)
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.
For further information contact:
Ms. Polly Neely
Senior Marketing Manager