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VISX, Incorporated is pleased to announce that the U.S.
Food and Drug Administration (FDA) has approved the use of the
topographically driven Custom-Contoured Ablation Pattern (Custom-CAP) Method,
under a Humanitarian Use Device exemption (HDE).
With Custom-CAP treatment, VISX physicians can now perform a treatment
precisely controlled by size, depth, and location, making it possible to
reshape the cornea for optimum correction. By using the VISX STAR S3
ActiveTrak™ Excimer Laser System together with a Zeiss/Humphrey® Atlas™
corneal topographer and associated VisionPro™ Ablation Planning Software,
physicians are able to address decentrations resulting from a previous
treatment on any brand of laser.
Indications
Custom-CAP treatment is indicated for the treatment of asymmetrical ablation
patterns from previous laser refractive surgery caused by decentration of the
treatment. Indicated patients include those who:
- Exhibit symptomatology supportive of visual defect: reduced best
spectacle-corrected visual acuity, debilitating glare, monocular diplopia
(double vision), and/or debilitating halos; and,
- Pre-operatively have at least a 6 micrometer difference on the elevation
topography, from the lowest point to the highest point, over a 6.5mm diameter
or over the patient's pupil diameter as measured by the Humphrey topographer,
whichever is larger.
"This indication will permit physicians to assist patients who were
previously untreatable with conventional laser ablation methods. Treating
these patients is a top priority for VISX and all refractive surgeons,"
said Steven Trokel, MD. "This demonstrates the capability of the VISX
platform to conduct customized ablations and complements the multi-center
U.S. FDA clinical trials on wavefront guided ablations that are
underway."
What is a Humanitarian Device Exemption (HDE)?
An HDE authorizes the marketing of a device that is intended to benefit
patients in the treatment and diagnosis of diseases or conditions that affect
or is manifested in fewer than 4,000 individuals in the United States per
year.
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